Quality Assurance Manager

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

*** Sponsorship not provided | must be eligible to work in the UK ***

QUALITY MANAGER - MEDICAL DEVICES

LOCATION: EAST ANGLIA - HYBRID

Develops, implements and maintains the activities of quality control systems. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Develops budget and monitors expenditures. Ensures all aspects of ISO13485, relevant standards and applicable regulatory requirements are met and upheld within the QMS and the Organisation.

Makes recommendations for corrective action necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations. Selects, develops and evaluates personnel to ensure the efficient operation of the function. First level of managerial position. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Works on issues of a diverse scope where analysis of situation or data requires evaluation of a variety of factors. Typically manages a department of Professional track employees but may also have support track direct or indirect reports.

Duties & Responsibilities

• Ownership & management of customer complaints investigations (CAPA) with focus on preventive actions implementation and their effectiveness verification; preparation, analysis & distribution of associated KPI metrics
• Active participation in continuous improvement and maintenance of company’s integrated QEHSMS accredited to ISO13485/9001/14001/45001 with the emphasis on medical devices manufacturing compliance – development, review & update of relevant QEHSMS documentation; internal audits etc.
• Active participation in suppliers quality management – review & approval process ; supplier audits ; purchased product control plans preparation, review and approval
• Risk management oversight: preparation of process FMEAs, manufacturing process verification & validation management
• Participation in Optical Measuring System programming for inspections of purchased product (training provision to be given)
• Quality Engineering support as part of day‑to‑day business as well as part of the cross‑functional teams for continuous improvement activities
• Any other duties and responsibilities as required

Technical Requirements

• Working Knowledge of ISO13485/9001/14001/45001 with the emphasis on medical devices manufacturing compliance – development
• Workplace Health and Safety Legislation