Quality Assurance Manager

6 days ago


Ely, Cambridgeshire, United Kingdom Force Recruitment Full time
About the Role

Force Recruitment is seeking an experienced Quality Assurance Manager to join our client, a leading life sciences and medical device business based in the UK. As a key member of the team, you will be responsible for leading the company's quality management systems and ensuring compliance with relevant regulations.

Key Responsibilities
  • Regulatory Compliance: Obtain and maintain IVDR, CE, and UKCA marks for current and new product portfolios.
  • Quality Management Systems: Maintain and ensure compliance with ISO9001:2016, ISO13485, and ISO17025 standards, and establish ISO15189.
  • Quality Assurance and Control: Oversee all Quality Assurance (QA) and Quality Control (QC) activities within the manufacturing site.
  • Continuous Improvement: Plan, initiate, and manage quality improvement projects to enhance product quality and process efficiency.
  • Audits and Inspections: Prepare for and manage internal and external audits by regulatory bodies such as BSI, and UKAS, and conduct external audits of contractors and suppliers.
  • Technical and Quality Support: Provide expert advice and support to sales, technical, and management teams, as well as other stakeholders.
  • Data Monitoring and Decision Making: Monitor quality data daily, take appropriate action, and make decisions or escalate issues as necessary.
  • Supplier Quality Assurance: Lead Quality Control, document control, validation, calibrations, and develop key supplier partnerships for Quality Assurance.
  • Training and Development: Develop and deliver quality training standards and manage the Quality Department's annual training and competence development programs.
  • Leadership and Management: Lead the Quality Department, ensuring targets and objectives are met, and foster a culture of continuous improvement in manufacturing practices.
Requirements
  • A bachelor's degree in quality, Science, Engineering, or a related technical field is desirable.
  • Extensive experience in a quality management position, preferably within a manufacturing and distribution environment is essential.
  • Prior experience maintaining a QMS aligned with ISO13485 and ideally ISO15189, and experience with ISO9001:2016 and ISO17025.
  • Proven experience in preparing for and conducting internal and external audits, with a relevant audit qualification or significant audit experience is essential.
  • Previous experience in attaining CE/UKCA marking and familiarity with IVDD/IVDR regulations.
  • Strong understanding of common problem-solving tools, with Lean Six Sigma certification required.
  • A thorough understanding of manufacturing systems, processes, and products, with a solid working knowledge of industry practices is essential.


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