Quality Assurance Manager

Join a leading EO (Ethylene Oxide) sterilisation plant dedicated to providing safe, effective, and high-quality sterilisation solutions. We are committed to ensuring our processes meet the highest industry standards, ensuring the safety and reliability of medical devices and other critical products.

We are seeking a Quality Manager to lead our Quality Assurance and Control teams. As the Quality Manager, you will play a pivotal role in ensuring our sterilisation processes comply with regulatory standards. You will also drive continuous improvement initiatives and foster a culture of quality throughout the organisation. You will maintain the Quality Management System (QMS) within the Somercotes Facility.

Key Responsibilities:

• Is the nominated Facility Management Representative with respect to ISO9001/13485/ 21 CFR Pt820
• Lead and manage the quality department, overseeing all quality assurance and control activities.
• Develop and implement quality management systems (QMS) and procedures to maintain best practices.
• Conduct regular audits (internal and external) and manage customer audits and regulatory inspections.
• Oversee root cause analysis, CAPA processes, and quality-related investigations.
• Collaborate with production, R&D, and regulatory teams to ensure all products and processes meet stringent quality standards.
• Lead continuous improvement initiatives aimed at optimising quality processes and reducing risk.
• Provide training and guidance to staff on quality principles and regulatory requirements.
• The QA Manager has responsibility for the QA Technicians and Validation coordinators within the Somercotes facility. 

Qualifications & Experience:

• Proven experience as a Quality Manager, ideally within EO sterilisation or a regulated manufacturing environment.
• In-depth knowledge of relevant standards.
• Strong background in managing quality systems, audits, and regulatory compliance.
• Excellent leadership and communication skills, with the ability to influence across departments.
• Degree in a relevant scientific or engineering discipline is desirable.