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20 Healthium Medtech Jobs
Senior Manager - QA | 12 To 15 years | Peenya Office, Bengaluru
12-15 years
Bangalore / Bengaluru
1 vacancy
Senior Manager - QA | 12 To 15 years | Peenya Office, Bengaluru
Healthium Medtech
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Maintain readiness for unannounced audits by notified bodies, MOH and USFDA at all times.
- Act as the Management Representative (MR) for the site, ensuring compliance with regulatory standards.
- Ensure cross-functional teams are prepared for ongoing audits with updated and relevant documentation.
- Develop risk management and design documentation in accordance with established SOPs.
- Oversee the control, preparation, approval and issuance of all departmental SOPs, formats and records.
- Plan and conduct Internal Quality Audits (IQA), follow up on NCs (Non-Conformities) and compile summaries for final reports.
- Coordinate the calibration and validation of equipment and instruments with external agencies, maintaining updated reports.
- Investigate and resolve export-related customer complaints in collaboration with QC and production teams.
- Organise and conduct regular QMS meetings, addressing key issues and driving improvements.
- Respond to customer queries related to complaints, quality, manufacturing processes and Certificates of Analysis (COAs).
- Track and compile monthly quality objective reports.
- Perform duties as the Person Responsible for Regulatory Compliance (PRRC).
- Collect documents and prepare Management Review Meeting (MRM) reports.
- Verify actions and close NCRs (Non-Conformance Reports).
- Raise and manage CAPAs (Corrective and Preventive Actions) for internal and external observations, providing justifications for closure.
- Authorise product releases in compliance with quality and regulatory standards.
- Experience in manufacturing facilities for EUMDR and 510 K approved medical devices is mandatory.
Employment Type: Full Time, Permanent
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