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Quality Head

4 weeks ago

Chennai, India SAI Hr Consultants Full time

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