Reporting to the Head of UK Quality, the Quality Engineer is responsible for defining and maintaining the quality criteria for all company products and ensuring those criteria are consistently met. You will be the custodian of the Quality Management System, playing a lead role in internal and external audits, non-conformance investigation, corrective action, and continuous improvement. This is a hands-on, cross-functional role that sits at the heart of manufacturing operations.
What You Will Be Doing
* Maintaining and developing the Quality Management System to ISO 13485 and ISO 9001 standards, including preparation for and participation in third-party external audits.
* Leading root cause analysis and corrective action processes, using tools such as 8D and CAPA to drive systematic improvement.
* Managing non-conforming product investigations, customer complaints and field returns through to resolution.
* Supporting production with inspection criteria, first-off checks for new product launches and ECNs, and the development of work instructions.
* Preparing and maintaining Quality Control plans using a risk management-based approach.
* Assisting the Person Responsible for Regulatory Compliance (PRRC) with international regulatory registrations including EUDAMED, FDA, GUDID and MHRA.
* Driving a culture of quality excellence across the business by engaging cross-functional teams and championing continuous improvement.
* Supporting the UK Health, Safety and Environment Manager to ensure aligned compliance with ISO 14001 and internal HSE requirements.
What We Are Looking For
Essential
* A relevant qualification in Engineering, Quality or a related discipline.
* Demonstrable experience in a quality role within a manufacturing environment.
* Practical knowledge of ISO 9001 and ISO 13485 Quality Management Systems.
* Experience with problem-solving methodologies, error-proofing and corrective action tools including 8D and CAPA.
* Competence in root cause analysis and the ability to translate findings into effective, sustainable actions.
* Internal auditing experience and confidence in supporting external auditors.
* Familiarity with ERP or MRP systems and experience using measuring and calibration equipment.
* Strong analytical skills with the ability to compile reports and make practical recommendations.
* Excellent communication and influencing skills, with the ability to build productive relationships across all levels of the business.
* Willingness and ability to travel to other sites when required.
Desirable
* Internal auditor training in ISO 13485, ISO 9001 or ISO 14001.
* The ability to read and interpret engineering drawings, specifications and standards.
* Experience of lean manufacturing principles and continuous improvement methodologies.
* A background in medical devices or similarly regulated product environments.
* Familiarity with Safety, Health and Environmental Management Systems.
Why Consider This Role
This is an important role within a global organisation and there are genuine opportunities for ambitious candidates.
Salary £38/ 43,000 plus benefits.
This role is being handled exclusively by Simpson Recruitment Services. For a confidential discussion or to register your interest, please send your CV to Gary Simpson
Salary description
£38000.00 - £43000.00 per year