Current Opportunities

At Omya Healthcare, we strive to make medical devices, accessible and affordable, and to rationalize the cost of care delivery. We invites the people to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access, and improving quality and efficiency in the emerging world.

We believe in our long-term strategy and we'd like you to be part of it. We believe that something remarkable can happen when we bring together people from multiple discipline, who are committed to make a difference.

We are looking to appoint new candidates at different locations as mentioned below :-

Current Opportunities

Sr.Engineer/Designer R&D

Sr.Engineer/Designer R&D

Experience plus 2-5 years Medical Device field of proven experience
Location Bangalore
Education Masters / Bachelor’s degree / Technical Graduate / Biomedical Engineering
Job Description

Job Description
Required:  Bachelor’s degree in Mechanical Engineering plus 2-5 years Medical Device field experience (or a Master’s Degree plus two years of related experience) in the Research and Development of a technological product is required, Use multidisciplinary engineering knowledge to lead and contribute to a team designing and developing innovative mechanical and electro-mechanical medical devices or components/subsystems in support of company’s strategic plan.

 

Skill Set

Job Summary: 
Responsible for supporting product development projects and risk management activities. 
Major activities include, but are not limited to:

  • Execute risk management activities in accordance with ISO 14971 throughout product development lifecycle.
  • Partner with Quality to identify/ explore areas of reliability, risk, and sampling for each assigned project.
  • Develop test strategies to determine the best means of providing design verification and reliability.
  • Provide oversight to and verification of process validation procedures to ensure they are adequately followed during product development
  • Apply statistical techniques and knowledge to guide testing strategies and protocol design
  • Conduct Design History File audits, support internal audits of design control and risk management systems.
  • Will have responsibility to deliver engineering documents, conduct engineering reviews
  • Support Risk Management Activities: Update existing risk analyses as needed from Non-conformance Reports, Complaints.
  • Support development and completion of validation activities for equipment and processes to support product development. 
  • Ensure appropriate qualifications activities are performed and documented in compliance with CE/FDA Requirements
  • Plan time and priorities in an effective manner to achieve all tasks assigned with the objective of assuring data integrity and compliance.

Skills and Experiences:

  • Medical device product development (ISO, GMP, FDA, CE) and design controls
  • Risk Management (ISO 14971) /Quality Assurance
  • CE/FDA Compliance testing and documentation
 
Service engineers

Service engineers

Experience 3 -4 Years
Location Bangalore
Education Biomedical degree/ diploma holders
Job Description

Roles and responsibilities

- Install Devices in Hospitals

- Attend to service calls as per SLA’s

- Operates system to demonstrate equipment and to analyse malfunctions

- Interprets maintenance manuals, schematics, and wiring diagrams, and repairs equipment using standard test instruments

- Consults R&D team to resolve unusual problems in system operation and maintenance.

Skill Set

- Must have 3-4 years of proven experience in Servicing Medical devices in Critical care - Preference will for candidates with Service experience of Syringe pumps and patient monitors - Biomedical degree/ diploma holders; Familiar with Microsoft office.

 
Regional Manager: ( Marketing , Sales & Service )

Regional Manager: ( Marketing , Sales & Service )

Experience 6 to 10 years relevant field experience on any medical equipment preferably critical care equipments.
Location Bangalore
Education Diploma in Engineering/BE/Equivalent Technical Qualification in Electrical / Electronics / Physical Sciences.
Job Description

Roles and Responsibilities:

  • Planning , Organising & Managing team of Sales and Service People
  • Executing the assigned target through the team members and maintain the customer delight.
  • Understanding requirements , submission of appropriate proposals &
  • Participation in the negotiating process towards successful closure.
  • Customer Engagement.
  • Understand and applicable knowledge of pre tender work to execute facilitate tender orders
  • Monitoring & guiding the team on a daily baiss to achieve the Sales goals on weekly /monthly/quarterly basis.
  • Manage and deliver profit for the zone.
  • Create and maintain relationship with KOL for business growth
  • Penetrate and establish existence in various hospitals and fall upon the business of Rate contract basis.
  • Capable of handling high volume/ turn over business and deliver proper profit to the organisation and to create growth opportunities for  the team members.
  • Mentoring coaching and giving proper motivation to the team to help achieve and execute the targets.
  • Feedback to the R&D team regarding the competition, products in market,technology trends & potential new products for future development/business.
  • Establishing & Implementing the systems & process as per the company CRM & generation of timely reports needed for MIS.
  • Liasoning & participating in the Post Market Surveillance study.
  • Implementation of the QMS & the applicable regulatory systems & procedures.
Skill Set

Omya is looking for a Leader who is very Aggressive, Dynamic personality with very strong competencies in Marketing, Sales and service in Medical Device Field and to take Omya’s branded Medical Devices to Indian and International Markets, Should be fluent in English, Hindi and regional languages - Should have an expert knowledge in MS office - Graduate in any discipline.

 
Graphic Designer - 1 Opening(s)

Graphic Designer - 1 Opening(s)

Experience 1-2 years
Location Bangalore
Education Any
Job Description

Roles and Responsibilities: 

Supporting the organization with; 

  • Print Media: Graphical Illustration and Designing for Brochure, Book let, Profile, flyers, Newsletter, Posters, Invitation, Office stationeries, Palm let and advertising materials in all media (under branding module)
  • Web Applications: Periodical updating of the website and web banner, Press release, Template for graphical presentation, 
  • Coordinate printing/graphics vendors, provide project specifications and is responsible for insuring accurate production of designed pieces.
  • Support, Create, develop and execute presentation materials, such as desktop presentations, scientific posters, and conference materials. 
  • Responsible for the creation and production of product and promotional marketing communications collateral to support the marketing and sales team
  • Critical thinking and ability to prioritize, organize, manage information, and complete projects.

 

 

Skill Set

Software :  Graphical Illustration, CorelX5, Adobe Photoshop, Dream weaver, Flash, Adobe Premier In Design, 

Platform: Windows, MS Office.

Key Skills: Typography and visual arts, Branding Technique, Communication design, Composition and Page layout, User Interface 

 
Mechanical Engineer /Graduate Engineer Trainee

Mechanical Engineer /Graduate Engineer Trainee

Experience Required: plus 1-2 years Medical Device field experience - Bachelor’s degree in Mechanical or Biomedical Engineering
Location Bengaluru, Karnataka, India
Education Bachelor’s degree in Mechanical or Biomedical Engineering
Job Description

Description :

Looking for a degreed Engineer with experience working in Medical Device field. 
Familiar with engineering calculations, plastics and sheet metals and Solid Works is a plus
Realize the requirements and interact with multidisciplinary team, implement it with highest quality and on time.

Ability to work in a fast-paced, deadline oriented environment as part of a team

Skill Set

Job Summary: 

  • Analyzes, designs, develops solutions to engineering challenges to meet project objectives.
  • Will have responsibility to deliver engineering documents, conduct engineering reviews and may be involved with implementation oversight.
  • Design sub-assemblies to meet broad design goals, establish requirements and specification
  • Use empirical, numerical and experimental analysis to analyze designs
  • Involved in test method and model development
  • Identify and mitigate sub-assembly risks
  • Support invention disclosures
  • Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations
  • Support pre-clinical and clinical testing of devices
  • Experience designing and testing medical devices preferred
  • Exposure to a variety of manufacturing processes and designing for manufacturability preferred
  • Familiarity with medical device product development (ISO, GMP, FDA, CE) and design controls
 
Graduate Engineer Trainee / Product designer

Graduate Engineer Trainee / Product designer

Experience Required: plus 1-2 years Medical Device field experience - Bachelor’s degree in Mechanical or Biomedical Engineering
Location Bengaluru, Karnataka, India
Education Bachelor’s degree in Mechanical or Biomedical Engineering
Job Description

Description :
Looking for a degreed Engineer with experience working in Medical Device field. Familiar with engineering calculations, plastics and sheet metals and Solid Works is a plus

Skill Set

Job Summary: 

Analyzes, designs, develops solutions to engineering challenges to meet project objectives.
Will have responsibility to deliver engineering documents, conduct engineering reviews and may be involved with implementation oversight. 
Design sub-assemblies to meet broad design goals, establish requirements and specification
Use empirical, numerical and experimental analysis to analyze designs
Involved in test method and model development
Identify and mitigate sub-assembly risks
Support invention disclosures
Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations
Support pre-clinical and clinical testing of devices
Experience designing and testing medical devices preferred
Exposure to a variety of manufacturing processes and designing for manufacturability preferred
Familiarity with medical device product development (ISO, GMP, FDA, CE) and design controls

 
General Manager - Marketing, Branding, Sales and Service.

General Manager - Marketing, Branding, Sales and Service.

Experience 18 to 22 years relevant experience in handling marketing sales & services operations of a medical device environment.
Location Bangalore
Education Graduate / Post graduate in Engineering / Bio Medical / Electronics. Post graduate in Management
Job Description

Roles and Responsibilities:

  • Responsible for the Marketing, Branding, sales & service operations of Omya products in the Indian Market & other SAARC & MENA countries.
  • Overall responsibility of the P&L, cash flows, business & quality targets.
  • Achieving deeper penetration & traction in the market by branding as Technology Company.
  • Establishing new business partners in the market.
  • Reviewing the team performance on a regular periodic basis & Reporting to the Top Management.
  • Reviewing & realigning the business forecast, pitching efforts, prospects handling to achieve the business goals.
  • Recruiting, managing & motivation the team members towards performance & achievements.
  • Managing & improving the Dealer network & business.
  • Overall monitoring of the Servicing activities to ensure that the down time at locations are at low levels & improving.
  • Implementation & monitoring for effective use of a company specific CRM process.
  • Monitoring & tracking of various budgets & targets.
  • Collaboration with the R&D team to provide insights wrt newer products, technology improvements & trends, competitor information & data, & feedback on products.
  • Liasoning & participating in the Post Market Surveillance study.
  • Implementation of the QMS & the applicable regulatory systems & procedures.
Skill Set

Omya is looking for a Leader who is very Aggressive, Dynamic, Entrepreneurial personality with very strong competencies in Marketing, Branding, Sales and service in Medical Device Field and to take Omya’s branded Medical Devices to Indian and International Markets .

 
Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist

Experience Minimum of 5 years experience in regulatory medical device industry products regulations
Location Bengaluru, Karnataka, India
Education Education Graduate / Post graduate in Engineering / Bio Medical / Electronics. Post graduate in Management
Job Description

An experienced, high caliber Senior Regulatory Specialist to lead project submissions for regulatory approvals and who acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional teams and partners , demonstrates strategic thinking and creativity in support of programs.
In depth experience in Medical Device Directive, ISO 13485, IEC 60601, includes ISO 14971, IEC 62304 etc., with FDA requirements, guidance documents, 510(k) submissions, and other global regulatory requirements and quality standards involvement with regulatory submissions, interactions with regulatory agencies, and working with cross-functional project teams.

Skill Set

The position will participate in the development of product specifications, ensuring project compliance to internal and external standards, and regulatory compliance, coordinating the risk analysis activities, and creating and managing the quality engineering deliverables.
Devising solutions in product design to meet the regulatory requirements like CE marking, FDA etc.
Ensuring that the design process meets the Regulatory Compliance Plan by reviewing the process throughout the Product Life Cycle.
Identifying and incorporating regulatory requirements in the design of new Products and process in coordination with the cross functional teams from India and overseas for medical products
Product support to currently marketed products. Work with engineers and technical experts to evaluate proposed changes to products for regulatory impact and to develop necessary documentation
Governmental approvals to introduce new and modified products to the market
Regulatory submissions and negotiates their approval
Developing regulatory strategies, preparing CE / US FDA submissions, providing documentation for international submissions,  evaluating proposed product changes for regulatory impact and preparing necessary documentation
Prepare submissions for new products and their product changes as required to ensure timely approval for clinical studies and market release
Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
Evaluating proposed product changes for regulatory impact and preparing necessary documentation
Provide regulatory support by reviewing labeling, promotional materials, training materials,changes to existing devices and documentation. Prepare ubmissions and reports for regulatory agencies as required.
Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Keeps current on global directives, harmonized standards and procedures and communicates changes that may effect cross functional areas.
Knowledge and experience with  Experiencein Class II, III medical devices will be desirable

Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 
AM - Manufacturing Process Engineering

AM - Manufacturing Process Engineering

Experience More than 7 years of experience in areas of Process Development and Manufacturing - Medical devices
Location Bengaluru, Karnataka, India
Education B.Tech/BE Graduate / Technical Graduate
Job Description


Required more than 7 years of experience in Process development and Manufacturing for ISO regulated manufacturing Medical Device environment.
Experience with lean six-sigma manufacturing and preferably, green-belt certified, Process automation
Strong knowledge with regulatory requirements (e.g. ISO 13485, ISO 14971, CE & FDA, GMP)
Good working knowledge on manufacturing methods, and an ability to effectively persuade people of all different levels within the organization
Understanding and implementation in six-sigma manufacturing, green-belt certified, FMEA, control plan, Process automation, Process capability improvement, 5S, kaizen, kanban, poka-yokes, etc.
Ability to prioritize and work independently, Oral and written communication skills,

Skill Set


Co-ordinate with R&D, Responsibility with Quality Assurance and Production. Participate in design reviews with R&D team and take actions to improve the manufacturability of the product.
Develop new manufacturing processes and equipment technologies to enable low cost, high quality manufacturing, provides floor support to assigned product lines.  
Establish and improvise the manufacturing processes  through Manufacturing Process Plan, identify deviations and take corrective actions to ensure process compliance.
Responsible as Management Representative for conducting audits internally and externally with sub-contractors, MRM review on quality systems, processes, and products to ensure compliance with regulations. 
Assist with the design and development of gages, fixtures, and tooling,  tolerance analysis and process FMEA & process validation,  Design and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)
Engage in the early stages of Component Development Process and manufacturing transfer of new products through support of the pilot team. 
Identify, communicate, select and qualify suppliers/Contract Manufacturers
Coordinate and execute activities, transfer technology, processes or other information between, within the department and Contract Manufacturer
Work out pre study analysis to determine cost/benefits, manufacturing financial forecast, operating plans,  risk potentials for new product launches.
Manage the process to ensure that workplace conditions comply with an occupational health and safety standard and requirements
Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product  and regulatory requirements
Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
Participate on cross-functional teams to review marketing requirements and feasible product requirements and coordinate for process validation plans and protocols, and conduct validation testing of new or update products as necessary. 
Participate along with QA team in the development of corrective and preventative action plans and coordinate closure of actions with assigned responsible parties. Assure and track the timely closing of all variances, CAPAs and audit findings 
Works with suppliers to complete change requests, risk mitigation projects and supplier related cost savings initiatives.
Meet objectives and timelines as outlined by Project Management.  Communicate all aspects of project tasking in a professional manner to all Team members and management to facilitate corporate objectives.

Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 
Sr. Clinical Research Associate

Sr. Clinical Research Associate

Experience 3-4 years of experience in conducting clinical research & clinical trial in the medical device industry
Location Bengaluru, Karnataka, India
Education Bachelor’s Degree in Science or Healthcare Related Field or Biomedical Engineering
Job Description

Strong knowledge and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Working knowledge of regulations and standards applied in clinical area and medical devices is essential.
Knowledge and experience with ISO 14155, ISO 13485, ISO 14971, 21CFR 820,  etc., 
Experience monitoring approval and surveillance studies in support of 510(k) clearance
Demonstrated strong communicator, verbal and written, across all levels of the organization as well as cross functionally

Skill Set

Performs scientific literature searches as needed to support team members, Review and provide feedback on collateral material in development.
Participates in the design, administration and oversight of clinical and human factor/ergonomic studies. Studies may be conducted as either Investigator Initiated or Sponsor initiated studies. 
Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies, staying informed about applicable clinical landscapes and trends.
Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements 
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
May provide assistance with design of study tools, documents and processes.
Collaborate and liaise with study team members for project execution support as appropriate.
Must have ability to travel for Clinical relavance/studies
Perform statistics, statistical methods, and design of experiment.
Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies.

Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 
Strategic Planning Analyst

Strategic Planning Analyst

Experience Required: 0-2 years Experience in medical devices and/or healthcare industry is highly preferred.
Location Bengaluru, Karnataka, India
Education Requires a MBA Finance degree. Excellent analytical, critical thinking, problem solving, relationship building and communication skills.
Job Description

Omya Healthcare is building its Strategic Planning team and is seeking exceptional candidates acts as an internal consulting focused on developing growth oriented strategies for the organisation. 
Seeking a resourceful, energetic professional for this entry-level position.  In this position, the Strategy Analyst will provide project management, analytics, financial modeling, business planning, and other support within Strategic Planning.
he Strategy Analyst supports initiatives led by these functions, including entity, service line, and market strategic planning efforts, business development efforts that might include joint ventures, partnerships and M&A, and/ or strategic initiatives that might include unique, cross-cutting projects outside the normal course of business.
Bachelor's degree is required, MBA preferred business, finance, accounting, or audit experience required
First-hand knowledge of and experience in financial statements, valuation modeling techniques and methods, and business case development required.
Experience in medical devices and/or healthcare industry is highly preferred.
Substantial experience managing diverse projects and teams, as well as presenting findings to senior management in a timely and professional manner required.

 

Skill Set

Supports the projects of the Strategic Planning and Business Development & Strategic Initiatives functions. The Analyst will routinely partner with other members of the management team, and will work directly with other internal and external stakeholders.
The role requires the ability to develop business questions, identify and gather relevant data, structure data into a usable format, explore the data through analysis until insights are gleaned, and communicate insights to various audiences to support decision making.
Make technological connections by rapidly assimilating information from literature, scientific meetings (internal and external), scientists and engineers, scientific technical concepts, theories and experimental data.
Designs and project manages targeted research projects which includes identifying data sources, collecting data from various sources, analyzing data using one or more quantitative techniques, and ultimately deriving strategic insights from the data. Uses the information gathered to develop standard reports. Draws conclusions about trends, variances (against plan, year-over-year, etc.) and business performance. Presents information and distributes reports.
Performs detailed analytics, which may include internal or external financial, operational and/or market data, and is able to summarize into key insights for project leaders.
Communicates effectively, including verbal and written communications, and will often work, directly and indirectly, with senior leaders across the healthcare system.
Participates in cross-functional teams and operates within different levels of the organization.
Requires flexibility and the ability to adapt to changing project and stakeholder demands.
Desired skills include strong analytical, critical thinking, problem solving, relationship building, and communication skills. Previous experience with PowerPoint and Excel is preferred.

 

 
Sr. Product Expert / Subject Matter Expert

Sr. Product Expert / Subject Matter Expert

Experience Required: plus 3-5 years Medical Device field experience - Bachelor’s degree in Mechanical or Biomedical Engineering
Location Bengaluru, Karnataka, India
Education Education Graduate / Post graduate in Engineering / Bio Medical / Electronics. Post graduate in Management
Job Description

Job Description
Master’s/Bachelor’s degree in Engineering plus 2-5 years Medical Device field experience and Research and Development of a technological product is required
Use multidisciplinary engineering knowledge to lead and contribute to a team designing and developing innovative mechanical and electro-mechanical medical devices or components/subsystems in support of company’s strategic plan.

 

Skill Set

Professional experience with in-depth knowledge and hands-on experience of the bio medical theories, principles and practices of Critical Care Medical Equipments, Preferably experience in product such us Medical Ventilator, Syringe pump, volumetric pump and Patient Monitor.
Work along with design and development team for NPD studies such us Competitor product study, Product technology and Configuration, Tear down, Techinical and user requirements, defining Product specification for new products.  
Support R&D cross functional team in developing and bringing the next generation Life Saving Equipment medical devices to market.
Visiting the healthcare professionals, other medical professionals, such as doctors and therapists as well as with end-users (patients and their carers) to collect their need, findings and requirements, 
Participating in R&D, Marketing meeting and provide input for product design and development specification, provides innovative new ideas and features for new products.
Support on product development life cycle through concept and feasibility, risk analysis, prototyping, design V&V and designs transfer as needed for NPI process and quality systems, requirements.
Creating, Defining and Writting technical specifications for each NPD product, Product specific reports and creates presentations as required to document and market communication purpose.
Organising and maintaining the database of all orginational product lineup.
Developing the validation & verification protocol and test methods, manual and service procudures.
Identifying the risk hazards associated with the products, analysed and mitigated, using FMEA method 
Working with the medical standards such as ISO 13485, ISO 14971 and IEC 60601-1, as required. 
Skilled in detecting problems in medical equipment by providing troubleshooting solutions for problems arise in existing products. 
Familiar with the standards, codes, and regulations related with biomedical engineering
Proficient with MS Office suite and Internet search

"Disclaimer"

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 
Sr. QA & RA Executive

Sr. QA & RA Executive

Experience 3-4 years of experience in Quality Assurance & Regulatory affairs preferably in the Medical device Industry
Location Bengaluru, Karnataka, India
Education  B.Tech/BE, Graduate / Technical Graduate
Job Description

Candidate with a Degree in Engineering or equivalent and about 3-4 years of experience in Quality Assurance and Regulatory affairs in the Medical device industry. 
"In depth understanding of ISO 13485, CFR 820, CE & ISO 14971, GMP, prefered certified Internal Auditor. 
Experience in QMS, SOPs, IQ,PQ,OQ, CE submissions, other global regulatory requirements."
Demonstrate strong Communication, Verbal and Written skills

 

Skill Set

Responsible for Establishment and Implementation of QMS as per ISO 9001, ISO 13485, CE, FDA etc and other Regulatory approvals and working on Class II, III medical devices 
Responsible to get the registration of medical devices in india and other regulatory bodies.
Responsible as Management Representative for conducting audits internally and externally with sub-contractors, MRM review on quality systems, processes, and products to ensure compliance with regulations. 
Developing regulatory strategies, preparing CE / US FDA submissions, providing documentation for international submissions,  evaluating proposed product changes for regulatory impact and preparing necessary documentation
Interface between multidisciplinary departments, managers, regulatory agencies and vendors to ensure expectations are met like CE marking, FDA , Indian regulations etc.
Assist in risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
Review Design History Files and Technical Files for conformance to applicable regulatory requirements. Maintain Regulatory Affairs product files to support compliance with regulatory requirements and Approvals to introduce new and modified products to the market
Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications. 
Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
Participate in the development of corrective & preventative action plans and coordinate closure of actions with assigned responsible parties. Assure and track the timely closing of all variances, CAPAs and audit findings 
Keeps current on global directives, harmonized standards, procedures and communicates changes that may effect R&D and cross-functional team.
Effective problem solving skills, excellent analytical skills, strong attention to detail, structured and methodical. Independent judgment

"Disclaimer"

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 
QA/QC Engineer

QA/QC Engineer

Experience 2-3 years of experience in Quality Assurance & Quality Control, preferably in the Medical device Industry
Location Bengaluru, Karnataka, India
Education  B.Tech/BE Graduate / Technical Graduate
Job Description

Candidate with a Degree in Engineering and about 2-3 years of experience in Quality Assurance & Quality Control, preferably in the Medical device industry. 
In depth understanding of ISO 13485, CFR 820, CE & ISO 14971, GMP and should be certified Internal Auditor. Experience in SOPs, IQ,PQ,OQ, verification/validation. 
Demonstrate strong communication, verbal and written skills

 

Skill Set

Responsible for Quality Assurance and Quality management system as per ISO 13485 , CE & FDA and as part of QA support for New product development, 
Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
Interface between departments, teams, managers and vendors to ensure that regulatory expectations are met
Responsible for development and improvement of product assurance systems such as in-process quality assurance, statistical process control, calibration / preventative maintenance, non-conforming materials, product lot release testing, and finished goods control. Identify and develop test methods and fixtures as needed. 
Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
Review Design History Files and Technical Files for conformance to applicable regulatory requirements.
Process validation plans and protocols, and conduct validation testing of new or update products as necessary. 
Provide oversight and monitoring of all phases of design to ensure compliance and timely resolution. 
Participate in the development of corrective and preventative action plans and coordinate closure of actions with assigned responsible parties. Assure and track the timely closing of all variances, CAPAs and audit findings 
Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications. 
Reviews  Batch records, SOPs, Change Controls, Validation Reports and Equipment Qualification
Effective problem solving skills, excellent analytical skills, strong attention to detail, structured and methodical. Independent judgment
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not 
intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

"Disclaimer"

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 
Receptionist/ Front Office Executive (female Only, Contract Position)

Receptionist/ Front Office Executive (female Only, Contract Position)

Experience Min Exp Required: 3 years and above.
Location Bengaluru, Karnataka, India
Education Graduate in any Degree
Job Description

Main Job Tasks and Responsibilities

·         Answer telephone, screen and direct calls 
·         Take and relay messages
·         Provide information to callers
·         Greet persons entering organization
·         Direct persons to correct destination
·         Deal with queries from the public and customers
·         Ensure knowledge of staff movements in and out of organization
·         monitor visitor access and maintain security awareness
·         provide general administrative and clerical support
·         prepare correspondence and documents
·         receive and sort mail and deliveries
·         schedule appointments
·         maintain appointment diary either manually or electronically
·         organize conference and meeting room bookings
·         co-ordinate meetings and organize catering
·         monitor and maintain office equipment
·         control inventory relevant to reception area
·         tidy and maintain the reception area

Skill Set

Education and Experience

·         high school diploma generally required
·         knowledge of administrative and clerical procedures
·         knowledge of computers and relevant software application
·         knowledge of customer service principles and practices
·         keyboard skills
·         ability to work a switchboard

Key Competencies
·         verbal and written communication skills
·         professional personal presentation    
·         customer service orientation   
·         information management
·         organizing and planning
·         attention to detail
·         initiative
·         reliability
·         stress tolerance