Quality Assurance (QA) Manager
Medical Device manufacturer.
Based Northern UK – M62 / M1 circa Manchester, Leeds, Sheffield, Doncaster
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. Office access required 2-3 days a week.
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.
* 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.
HACCP & Environmental Compliance
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