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The Company

An exciting opportunity to work for a medical device company based in North England is now available for a Quality Assurance Engineering Manager. The role requires the successful candidate to take ownership of a multi disciplinary Quality team to guide them through existing and new procedures to ensure smooth execution of strategic objectives

The Role

The client is looking for an experienced hands-on Quality leader who has demonstrated experience in strategy execution and driving improvements in quality processes in line with the ISO13485 QMS.

The Job

• Manage day-to-day duties and priorities for the Quality Control and Quality Engineering teams.

• Utilize continuous improvement techniques in conjunction with cross-site departments which include Operations, R&D and Regulatory Affairs, and Engineering to streamline and simplify the Quality Management System processes and procedures.

• Manage and lead non-conformance investigations and document containment, root cause investigations.

• Provides technical leadership for a range of quality engineering activities including process change control, non-conformance investigations, SCARs, CAPA, quality continuous improvement projects and programs.

• Provides technical support for ISO 13485, MDR 2017/745 and 21CFR820 audits and technical submission reviews.

• Accountable for ensuring that all final inspection and testing is conducted in a compliant, efficient, and timely manner as per the requirements of the Quality Management System (QMS).

Key Requirements

- Experience working to ISO13485 (Non Negotiable)

- Solid understanding on Quality Engineering (Lean Six Sigma)

- Proven success managing across cross functional teams

- Deep understanding of manufacturing processes and scrapage reduction

- Excellent Interpersonal Skills