Quality Assurance Manager
1 day ago
Birmingham
Quality Assurance (QA) Manager Medical Device manufacturer. Based Northern UK – M62 / M1 circa Manchester, Leeds, Sheffield, Doncaster - Office 2-3 times per week. Base salary £60-70k (Negotiable) with Bonus and Package. Role Overview Our client is a global medical device manufacturer seeking an experienced and hands-on Quality Assurance Manager to lead their Quality function in a regulated manufacturing environment. This role is ideal for a Quality professional from the medical device, pharmaceutical, or chemical manufacturing sectors who can operate strategically and practically — including close collaboration with laboratory teams to support QA testing and compliance. The QA Manager will ensure regulatory compliance, maintain a robust Quality Management System (QMS), and drive a culture of quality, safety, and continuous improvement across the business. Key Responsibilities Quality Management & Compliance • Lead, maintain, and continuously improve the QMS in line with:, • ISO 9001, • ISO 14001, • GMP standards (applicable to the sector), • UK MDR (for medical device components, if applicable), • Ensure audit readiness at all times and maintain accurate quality records., • Manage document control, change control, and staff training compliance systems., • Lead Management Review and report on key quality metrics and KPIs., • Work closely with laboratory teams to oversee QA testing processes., • Ensure handling, testing, and documentation of products meet regulatory and safety standards., • Integrate quality systems within lab operations to maintain data integrity, traceability, and compliance., • Lead internal and supplier audits, ensuring effective follow-up and closure of CAPAs., • Prepare for and support external audits from certification bodies, MHRA, or other regulatory authorities., • Maintain and develop HACCP systems where relevant., • Ensure environmental compliance aligned with ISO 14001 standards., • Monitor and drive improvements in environmental, safety, and quality performance. Key Requirements • Proven experience as a Quality Manager in medical device, pharmaceutical, or chemical manufacturing., • Strong understanding of laboratory QA testing and ability to integrate with lab teams., • Practical experience with:, • ISO 9001, • ISO 14001, • HACCP, • GMP standards, • Experience leading and managing internal and external audits., • Strong knowledge of risk management, CAPA processes, and regulatory compliance., • Excellent organisational, leadership, and communication skills. Personal Attributes • Detail-oriented, proactive, and solutions-focused., • Comfortable working strategically and hands-on., • Confident engaging with auditors, regulators, and cross-functional teams., • Committed to fostering a culture of compliance, accountability, and continuous improvement. Why Join? • Leadership role with visible impact on quality, compliance, and operational excellence., • Opportunity to work across multiple regulated sectors — medical device, pharmaceutical, and chemical manufacturing., • Collaborative culture with close integration between lab, production, and operations., • Competitive salary and benefits package.