Danaher is hiring for a QA Professional at Radiometer, a Danaher operating company, for its India Development Center (IDC) in Bangalore. The role focuses on Quality Assurance activities across design control, product development, risk management, verification and validation, and regulatory compliance for healthcare and medical device products.
Job Details
| Details | Information |
|---|---|
| Company | Danaher – Radiometer |
| Position | QA Professional |
| Location | Bangalore, Karnataka, India |
| Job Type | Full-time |
| Work Mode | On-site |
| Experience | 5–7 years |
| Qualification | M.Tech / B.Tech / B.E. in Engineering preferred |
| Job Requisition ID | R1320049 |
| Posted | Today |
Position
QA Professional – Design Control
The QA Professional will be part of the QA Design Control team at Radiometer’s India Development Center in Bangalore. The position supports design control activities for products related to Immunoassays, Blood Gas, Transcutaneous Monitoring, and IT System solutions.
Responsibilities
- Lead Quality Assurance activities in design and development projects, including outsourced design.
- Ensure compliance with FDA, ISO, and global regulatory requirements.
- Provide guidance on design control elements including:
- Risk management
- Usability engineering
- Requirement traceability
- Cybersecurity
- Software lifecycle processes
- Review and approve design documentation, verification and validation protocols, and reports.
- Conduct risk assessments and maintain risk management files throughout the product lifecycle.
- Support design transfer and post-market activities.
- Collaborate with R&D, external partners, Supplier Quality, Operations, and Regulatory Affairs teams.
- Mentor junior QA team members and contribute to quality training programs.
- Support internal and external audits.
- Maintain knowledge of applicable standards and regulations.
- Drive continuous improvement and BDC-specific quality initiatives using Danaher Business System (DBS) tools.
Eligibility / Qualifications
The preferred educational qualification is:
- M.Tech / B.Tech / B.E. in Engineering
Candidates with other university-level education relevant to Quality Assurance may also be considered if they have strong technical understanding, can learn product-related technical aspects quickly, and can communicate effectively within a technical organization.
Experience
- 5–7 years of experience in Quality Assurance within healthcare or medical devices.
- Proven experience with design control processes and regulated environments.
- Experience with FDA 21 CFR 820, ISO 13485, MDR, and IVDR.
Required Skills
Candidates should have expertise in:
- Design control
- Risk management – ISO 14971
- Usability engineering
- Requirement management
- Systems engineering
- Cybersecurity
- Verification and validation
- IEC 62304 compliance
- Immunoassay principles
- Product lifecycle for immunoassay devices
- Hardware and software products
- Analytical performance verification
- Global regulatory standards
- System integration testing
- Lean process development
- Quality training and mentoring
Application Details
Interested candidates can apply for the QA Professional position at Danaher – Radiometer in Bangalore through the official job application page.
Job Requisition ID: R1320049
Location: Bangalore, Karnataka, India