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Quality Head
4 weeks ago
Job Description Quality Head (Medical Devices)
Position: Quality Head Medical Devices
Location: Chennai (Oragadam)
Experience: 15 22 Years
Industry Preference: Medical Devices, Precision Manufacturing, Electronics, Life Sciences
Role Overview
We are seeking a seasoned Quality Head with deep expertise in medical device manufacturing and ISO 13485 quality systems. This role will drive end-to-end quality leadership, ensure compliance with regulatory standards (FDA, EU MDR), and build a robust culture of quality across medical device vertical.
Key Responsibilities
- Lead and oversee the Quality Management System (QMS) compliant with ISO 13485, FDA 21 CFR Part 11/820, and EU MDR.
- Establish and monitor quality strategies, policies, and SOPs for medical device operations.
- Manage internal, external, and regulatory audits (ISO, FDA, CE, Notified Body).
- Ensure design controls, validation, and risk management are applied during new product introduction (NPI).
- Implement CAPA (Corrective and Preventive Action) and Root Cause Analysis for process improvements.
- Drive supplier quality management, including audits, approvals, and ongoing performance monitoring.
- Ensure compliance with cleanroom protocols, sterilization validation, and traceability requirements.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality by design.
- Lead and mentor a high-performing quality team to support medical device programs.
- Report key quality metrics to senior leadership and ensure customer satisfaction and zero defect delivery.
Candidate Profile
- Education: BE/B.Tech/ME in Mechanical, Electronics, Biomedical, or related field.
- Certification: Lead Auditor ISO 13485, Six Sigma (Green/Black Belt preferred).
- Experience: 1522 years in medical device quality assurance with at least 5 years in a leadership role.
- Strong knowledge of ISO 13485, ISO Risk Management), FDA QSR (21 CFR 820).
- Experience with process validation, equipment qualification, and sterilization processes.
- Hands-on with statistical quality tools, PPAP, APQP, SPC, MSA, FMEA.
- Proven leadership in scaling quality systems in global manufacturing environments.
What We Offer
- Opportunity to lead our medical device quality division.
Exposure to global regulatory frameworks and international clients
A culture of innovation, precision, and excellence.
- Competitive compensation and benefits.
Interested candidates can call me at
Thanks and Regards
L Sainath Jayaram
SAI HR CONSULTANTS
DIRECTOR TALENT ACQUISITION