Medical Devices QA Leader - ISO13485, CAPA, Hybrid UK

Wynne Consulting; Diss; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

Wynne Consulting is seeking a Quality Manager specialized in medical devices to oversee quality control systems and ensure compliance with ISO13485 standards. This hybrid role in East Anglia involves managing customer complaints, participating in continuous improvement processes, and conducting supplier audits. Ideal candidates will have over 5 years of experience in quality management within the medical devices sector, along with a strong background in risk management and regulatory compliance.

Qualifications

• 5+ years of experience in quality management, preferably in medical devices.
• Experience with CAPA and internal audits.
• Strong analytical skills and ability to manage diverse scope of issues.

Responsibilities

• Manage customer complaints investigations and preventive actions.
• Participate in continuous improvement and compliance with ISO standards.
• Conduct supplier audits and review purchased product control plans.
• Oversee risk management and FMEAs.
• Provide Quality Engineering support for continuous improvement activities.

Skills

Knowledge of ISO13485/9001/14001/45001

Risk management

Continuous improvement processes

Customer complaints management

Job description

Wynne Consulting is seeking a Quality Manager specialized in medical devices to oversee quality control systems and ensure compliance with ISO13485 standards. This hybrid role in East Anglia involves managing customer complaints, participating in continuous improvement processes, and conducting supplier audits. Ideal candidates will have over 5 years of experience in quality management within the medical devices sector, along with a strong background in risk management and regulatory compliance.