QA Manager - Medical Devices / Medical Manufacturing

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: 8-12 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 removed]