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Regulatory Compliance Specialist
2 months ago
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 regulatory standards.
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.
- 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.
