Quality Assurance Manager in Doncaster

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).
  • 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.
  • One direct head reports into the QA Manager.
• Laboratory & Product Quality Oversight
  • 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.
  • Support method validation, stability studies, and product testing as required.
• GMP & Audit Leadership
  • 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.
  • Implement and oversee GMP standards across production and laboratory operations.
  • 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.