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Quality Assurance Manager

2 months ago

Surrey, United Kingdom Diamond Search Recruitment Ltd Full time

Diamond Search Recruitment Ltd is seeking a highly skilled and experienced Quality Engineering Lead to join our client, a well-established and innovative medical device manufacturer.

About the Role:

The successful candidate will be responsible for the day-to-day supervision of the Quality Engineering personnel, ensuring the highest standards of quality and compliance are met.

Key Responsibilities:

  • Quality System Development: Suggest improvements to the Quality System and assist in its development to ensure it remains effective and efficient.
  • Leadership and Supervision: Deputise for the Head of QA and RA where permitted by procedures, providing guidance and support to Quality Engineers.
  • Quality Matrix Reporting: Report quality matrix data to the monthly Management Review Meeting in line with documented procedures.
  • Day-to-Day Supervision: Day-to-day supervision of quality engineers, ensuring they have the necessary resources and support to perform their duties effectively.
  • Investigation and Analysis: Assist in the investigation and analysis of internal failures, supplier quality issues, and customer complaints, identifying root causes and implementing corrective actions.
  • Final Inspection and Release: Conduct final inspection and approve release to market of finished goods, ensuring they meet the required quality standards.

Requirements:

  • Education: Degree in Science or Engineering.
  • Quality Assurance Background: Strong Quality Assurance background, preferably in the medical industry.
  • Process Validation Experience: Process validation experience, with a thorough understanding of EU MDR and MDSAP.
  • Regulatory Compliance: Understanding of Class 3 implantable medical devices, CE marking, EU device directives, and FDA regulations.
  • Auditing Experience: Experience in internal and supplier auditing, with a strong attention to detail and ability to identify areas for improvement.