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Qa Specialist I

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myGwork - LGBTQ+ Business Community

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Location:
India , Bangalore

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

The QA Specialist for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D. This position is part of the QA Design Control team, located at BDC (Bangalore Development Center) Bangalore. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. This position reports to the Director QA and is part of the QA Design Control team located at BDC (Bangalore Development Center) Bangalore and will be an on-site role. You will be a part of the QA Design Control team for supporting design control activities by working collaboratively with our QA colleagues from across the globe on products related to Immunoassays, Blood Gas, Transcutaneous monitoring and IT System solutions.

Job Responsibility:

  • Lead QA activities in design and development projects with a focus on Outsourced Design, ensuring compliance with FDA, ISO, and other global regulatory requirements
  • Provide expert guidance on design control elements including risk management (ISO 14971), usability engineering, requirement traceability, medical device testing (IEC 60601-1)
  • Review and approve design documentation, verification and validation protocols, and reports
  • Participate in supplier audit at Outsourced Design Partners
  • Facilitate risk assessments and contribute to risk management files
  • Support design transfer and post-market activities ensuring continuous compliance and improvement
  • Collaborating closely with R&D, external R&D partners, Supplier Quality, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities
  • Mentor junior QA team members and contribute to quality training programs
  • Keep up to date knowledge of standards, regulatory requirements and regulations applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system
  • Ensure that the projects and teams at BDC are Audit ready and provide support during the Internal and External audits of BDC
  • Provide support in driving BDC specific Quality initiatives
  • Demonstrate Danaher values and adopt DBS tools

Requirements:

  • M.Tech /B.Tech/BE degree in engineering, with strength in product design processes of multi-disciplinary products
  • 8 to 10 years of proven experience as a quality assurance professional in a Healthcare domain
  • Specialist in design control processes with experience in one or more of the following areas: Risk Management, Usability, Requirement management, systems engineering and architecture, Cybersecurity, Validation and verification
  • QA Design Control experience from the medical device or IVD industry or other similar regulated industries
  • In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA 21 CFR Part 820, ISO 13485, IVDR and MDR)
  • Must have knowledge and experience in working with ISO 14971 and IEC 60601-1
  • Process development and lean thinking
  • Mentor junior QA team members and contribute to quality training programs
What we offer:
  • Broad array of comprehensive, competitive benefit programs that add value to our lives
  • Health care program
  • Paid time off
  • Programs contribute to life beyond the job
  • Eligible for bonus/incentive pay

Additional Information:

Job Posted:
January 05, 2026

Work Type:
On-site work
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