Key Responsibilities:

- Lead and continuously improve the Quality Management System (QMS).
- Ensure compliance with ISO 13485, GMP, and regulatory requirements.
- Manage CAPA, NCRs, deviations, customer complaints, root cause analysis, and change control.
- Plan and coordinate internal, customer, supplier, and regulatory audits.
- Oversee incoming, in-process, and final product quality assurance activities.
- Manage validation, qualification, and quality risk management processes.
- Drive supplier quality performance and continuous improvement initiatives.
- Monitor quality KPIs and trend analysis to enhance operational excellence.
- Lead, mentor, and develop the QA team.
- Maintain audit and regulatory inspection readiness through effective QMS compliance.





Qualifications

- Education: Bachelors degree in Engineering, Life Sciences, Pharmacy, or related field.
- Experience: 7+ years in regulated manufacturing (medical devices/pharma preferred), with 3-5 years in a QA leadership role.
- Certifications: ISO 13485 Lead Auditor certification preferred.
- Industry: Medical Devices / Medical Manufacturing / Pharmaceutical

Skills required:

QMS, ISO 13485, GMP, CAPA, Root Cause Analysis, Auditing, Risk Management, and Process Validation.

Contact Details:

[email protected]

📌 QA Manager - Medical Devices / Medical Manufacturing (Oragadam)
🏢 Competition Team Technology
📍 Oragadam