In this role, you will have the opportunity to:
Design Control & Product Development:
- Lead QA Activities: Drive quality assurance in design and development projects, including outsourced design, ensuring compliance with FDA, ISO, and global regulatory requirements.
- Provide Expert Guidance: Advise on design control elements such as risk management (ISO 14971), usability engineering, requirement traceability, cybersecurity, and software lifecycle processes (IEC 62304).
- Review and Approve Documentation: Evaluate and approve design documentation, verification and validation protocols, and reports to ensure regulatory compliance.
- Facilitate Risk Management: Conduct risk assessments and maintain risk management files throughout the product lifecycle.
- Support Design Transfer & Post-Market: Ensure smooth design transfer and post-market activities, driving continuous compliance and improvement.
- Collaborate & Mentor: Work closely with R&D, external partners, Supplier Quality, Operations, and RA; mentor junior QA team members and contribute to quality training programs.
- Ensure Audit Readiness & Continuous Improvement: Maintain up-to-date knowledge of standards and regulations, ensure QA system updates, support internal/external audits, drive BDC-specific quality initiatives, and demonstrate Danaher values using DBS tools.
The essential requirements of the job include:
The ideal candidate should hold a M.Tech /B.Tech/BE degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.
- Experience: 5-7 years in Quality Assurance within Healthcare/Medical Devices, with proven expertise in design control processes and regulated environments (FDA 21 CFR 820, ISO 13485, MDR, IVDR).
- Technical Expertise: Hands-on experience in risk management (ISO 14971), usability, requirement management, systems engineering, cybersecurity, validation/verification, and IEC 62304 compliance.
- Domain Knowledge: Strong understanding of immunoassay principles and product lifecycle for immunoassay devices (hardware and software), including analytical performance verification.
- Process & Standards: Familiarity with global regulatory standards across major markets, system integration testing, and lean process development.
- Leadership & Mentorship: Ability to mentor junior QA team members and contribute to quality training programs
