Quality Head - Medical Devices Division- Oragadam Chennai

Position:

Role Overview

Quality Head

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 14971 (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

8015088704

sainathjayaram95@gmail.com