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Quality Assurance Manager
2 months ago
Job Title: Quality Manager
Job Description:
Our client, a leading life sciences and medical device business, is seeking an experienced Quality Manager to join their team. As a key member of the organization, you will be responsible for leading the CE and IVDD activities, ensuring compliance with relevant standards, and maintaining the highest quality across product portfolios.
The ideal candidate will have a proven track record in Quality Management, particularly in obtaining and maintaining IVDR, CE, and UKCA marks. You will oversee all Quality Assurance (QA) and Quality Control (QC) activities within the manufacturing site, plan and manage quality improvement projects, and provide expert advice and support to sales, technical, and management teams.
Key Responsibilities:
- Obtain and maintain IVDR, CE, and UKCA marks for current and new product portfolios.
- Oversee all Quality Assurance (QA) and Quality Control (QC) activities within the manufacturing site.
- Plan, initiate, and manage quality improvement projects to enhance product quality and process efficiency.
- Prepare for and manage internal and external audits by regulatory bodies such as BSI, and UKAS, and conduct external audits of contractors and suppliers.
- Provide expert advice and support to sales, technical, and management teams, as well as other stakeholders.
- Monitor quality data daily, take appropriate action, and make decisions or escalate issues as necessary.
- Lead Quality Control, document control, validation, calibrations, and develop key supplier partnerships for Quality Assurance.
- Develop and deliver quality training standards and manage the Quality Department's annual training and competence development programs.
- 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.
Apply now to discuss this exciting opportunity further.
