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
You'll also be a confident decision-maker with excellent attention to detail, self-motivated, resilient and flexible, with a can-do approach to your work.
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
You may have experience of the following: Quality Assurance Engineer, QA Engineer, Process Quality Engineer, Validation Engineer, Quality Systems Engineer, Manufacturing Quality Engineer, QA/QC Engineer, Medical Device Quality Engineer, Compliance Engineer, Quality Assurance Specialist
Salary description
£40000.00 - £45000.00 per year