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.