Quality Engineer

Salary : £40,000 - £45,000 DOE Location : Saffron Walden Working pattern: Full-time, Monday to Friday, 09:00–17:00 About the role Contamac manufacture polymers for contact and intraocular lens materials, including materials used in cataract surgery, and are based in Saffron Walden. They are recruiting a Quality Engineer to join the Quality Assurance team, helping ensure the business and its subsidiaries meet regulatory, compliance and strategic objectives. This role would suit a proactive, adaptable team player with strong communication skills, a positive problem-solving approach and the ability to work collaboratively across the business. What you'll be doing

Administer and improve the Quality Management System in line with business needs, notified body requirements and relevant international and European standards Support QA activities across the business, including technical files, deviations, root cause investigations, process improvements, product information and procedures Work with Operations to improve process controls, reduce scrap, support continuous improvement projects and maintain accurate process maps Conduct equipment qualifications and process validation, including protocol creation Contribute to risk assessments, CAPAs, deviations and periodic reviews Lead root cause investigations Perform internal audits to ISO 9001 and ISO 13485, including audit planning, non-conformance reporting, corrective action review and effectiveness checks Raise and track customer complaints, coordinate investigations, identify actions and monitor effectiveness Manage site equipment calibration activities, including SOPs, records, approvals, registers and third-party contractors Support customer, supplier and regulatory audits, covering ISO 13485, FDA and other applicable standards Develop and maintain relevant areas of the QMS to ensure continued compliance, best practice and business relevance Analyse QA, production and R&D data and present findings Write, review and amend SOPs and technical documentation Work collaboratively across the organisation to improve product and process quality, supporting other QA projects and investigations as required

What you'll bring Essential:

2+ years' experience in a highly technical manufacturing environment Experience with equipment qualification, process validation and protocol creation Strong technical written and spoken English Ability to influence, build relationships and support efficient cross-functional processes Clear communicator with good Microsoft Word and Excel skills

Desirable:

Internal and/or external auditing experience Lean Six Sigma qualification Understanding of ISO 9001, ISO 13485 and/or GxP BSc or equivalent in a relevant science or engineering subject