QA Professional

Overview

The QA Professional will ensure safe, reliable and compliant products during new product development and maintenance of existing product platforms by partnering with R&D. This role supports design control activities for products related to Immunoassays, Blood Gas, Transcutaneous monitoring and IT System solutions.

What you'll do

• Drive quality assurance in design and development projects, including outsourced design, ensuring compliance with FDA, ISO and global regulatory requirements.
• Advise on design control elements such as risk management, usability engineering, requirement traceability, cybersecurity and software lifecycle processes.
• Evaluate and approve design documentation, verification and validation protocols, and reports to ensure regulatory compliance.
• Conduct risk assessments and maintain risk management files throughout the product lifecycle.
• Ensure smooth design transfer and post-market activities, driving continuous compliance and improvement.
• Work closely with R&D, external partners, Supplier Quality, Operations and RA.
• Mentor junior QA team members and contribute to quality training programs.
• Maintain up-to-date knowledge of standards and regulations.
• Ensure QA system updates and support internal and external audits.
• Drive BDC-specific quality initiatives and demonstrate Danaher values using DBS tools.

What you'll need

• 5–7 years in Quality Assurance within Healthcare/Medical Devices, with proven expertise in design control processes and regulated environments.
• M.Tech, B.Tech or BE degree in engineering, with strength in product design processes of multi-disciplinary products.
• Other education at university level relevant for QA work may be accepted if the candidate has a good technical understanding, can learn the technical aspects in the products fast and can communicate in a technical organization.
• Experience with FDA 21 CFR 820, ISO 13485, MDR and IVDR.
• Hands-on experience in risk management, usability, requirement management, systems engineering, cybersecurity, validation/verification and IEC 62304 compliance.
• Strong understanding of immunoassay principles and the product lifecycle for immunoassay devices, including hardware and software.
• Experience with analytical performance verification.
• Familiarity with global regulatory standards across major markets, system integration testing and lean process development.
• Ability to mentor junior QA team members and contribute to quality training programs.

Details

• Location: IDC (India Development Center), Bangalore, Karnataka, India.
• This is an on-site role.
• The position reports to the Director QA.
• The role is part of the QA Design Control team.