Quality Assurance Manager

Quality ManagerJOB SUMMARY

Responsible for leading the Quality Management System (QMS) and ensuring compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 820, and applicable regulatory requirements within a medical device manufacturing environment.

The role provides leadership across quality systems, compliance, audits, supplier quality, CAPA, and continuous improvement activities.

KEY RESPONSIBILITIES

• Act as Management Representative for the QMS.
• Ensure QMS compliance with ISO 13485, ISO 9001, and FDA 21 CFR Part 820.
• Lead internal audits and support customer/certification body audits.
• Manage CAPA, complaints, and non-conformance investigations.
• Oversee document and record control systems.
• Ensure effective quality control and product disposition processes.
• Review and approve suppliers and support supplier qualification.
• Lead management review meetings and report on QMS performance.
• Drive continuous improvement initiatives across the QMS.
• Provide leadership to QA personnel, including training and performance management.
• Stop production/shipment when required to prevent non-conforming product release.

REQUIREMENTS

• 5–10 years’ experience in quality assurance/control in medical devices or regulated industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and medical device regulations.
• Experience with CAPA, audits, supplier quality, and QMS management.
• Familiarity with tools such as FMEA, DOE, and SPC.
• Strong leadership, communication, and organisational skills.
• Ability to work cross-functionally and support regulatory compliance activities.
• Willingness to travel for supplier audits and business needs.