Job Title:
Quality Manager – South Wales - Medical
About the Position:
We are seeking an experienced Quality Manager to oversee quality at our medical device company based in South Wales. This role involves managing an established team of QA and QC staff, ensuring compliance with regulatory requirements and implementing quality improvements.
Key Responsibilities:
* Compliance Management: Ensure adherence to ISO 13485, EU MDR, UK MDR, and FDA regulations.
* Quality System Management: Oversee the Quality Management System, maintaining its effectiveness and efficiency.
* Team Leadership: Manage a team of QA and QC professionals, fostering a culture of quality excellence.
* Quality Support: Provide guidance and support to manufacturing teams to ensure high-quality products.
* Project Management: Lead quality-related projects, driving process improvements and resolving issues.
* Representative Role: Act as the company's representative for quality matters, ensuring effective communication with stakeholders.
* QC Oversight: Monitor and maintain quality control processes, including CAPA, complaints management, and sterilization.
* Data Analysis: Analyze data to identify trends, areas for improvement, and opportunities for growth.
* Culture Development: Promote a culture where quality is integral to all departments' work.
* Audit Leadership: Lead internal audits and represent the site during external audits.
* Training and Development: Collaborate with departmental heads to provide quality training and development programs.
Requirements:
* Medical Device Quality Expertise: Proven knowledge of medical device quality systems, including ISO13485, 21 CFR Part 807, EU MDR, and UK MDR.
* Educational Background: Degree-level education.
* Leadership Experience: Substantial experience in a leadership or senior role within a quality department and team.
Salary: £60,000 - £80,000 per annum (dependent on experience)