Quality Engineer
Contamac · Direct employer
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
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
- 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
What's on offer
- 25 days holiday plus 8 bank holidays
- 5% company pension contribution
- Death in Service life assurance (4x salary)
- Free onsite parking
- Company social events
- Electric Vehicle scheme
- Cycle to Work scheme
Apply Now →
Application opens at the source listing. Free for jobseekers.