- Posted 06 September 2024
- LocationEly
- Reference1598
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Quality Manager
Job description
Our client based in Ely is an established life sciences and medical device business that is now looking to add an experienced Quality Manager to its team due to consistent growth and future plans.
This is an exciting opportunity for an experienced and ambitious Quality expert to take on a key leadership role within the organisation. The Quality Manager will be responsible for leading the CE and IVDD activities, maintaining compliance with relevant standards, and ensuring the highest quality across the product portfolios.
The ideal candidate will have a proven track record in Quality Management, particularly in obtaining and maintaining IVDR, CE, and UKCA marks. The role also includes the management of the quality management systems and oversight of Quality Assurance and Quality Control within the manufacturing site.
Main Duties & Responsibilities:
This is an exciting opportunity for an experienced and ambitious Quality expert to take on a key leadership role within the organisation. The Quality Manager will be responsible for leading the CE and IVDD activities, maintaining compliance with relevant standards, and ensuring the highest quality across the product portfolios.
The ideal candidate will have a proven track record in Quality Management, particularly in obtaining and maintaining IVDR, CE, and UKCA marks. The role also includes the management of the quality management systems and oversight of Quality Assurance and Quality Control within the manufacturing site.
Main Duties & 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.
- 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