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
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Administer and improve the Quality Management System in line with business needs, notified body requirements and relevant international and European standards
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Support QA activities across the business, including technical files, deviations, root cause investigations, process improvements, product information and procedures
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Work with Operations to improve process controls, reduce scrap, support continuous improvement projects and maintain accurate process maps
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Conduct equipment qualifications and process validation, including protocol creation
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Contribute to risk assessments, CAPAs, deviations and periodic reviews
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Lead root cause investigations
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Perform internal audits to ISO 9001 and ISO 13485, including audit planning, non-conformance reporting, corrective action review and effectiveness checks
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Raise and track customer complaints, coordinate investigations, identify actions and monitor effectiveness
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Manage site equipment calibration activities, including SOPs, records, approvals, registers and third-party contractors
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Support customer, supplier and regulatory audits, covering ISO 13485, FDA and other applicable standards
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Develop and maintain relevant areas of the QMS to ensure continued compliance, best practice and business relevance
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Analyse QA, production and R&D data and present findings
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Write, review and amend SOPs and technical documentation
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Work collaboratively across the organisation to improve product and process quality, supporting other QA projects and investigations as required
What you'll bring
Essential:
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2+ years' experience in a highly technical manufacturing environment
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Experience with equipment qualification, process validation and protocol creation
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Strong technical written and spoken English
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Ability to influence, build relationships and support efficient cross-functional processes
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Clear communicator with good Microsoft Word and Excel skills
Desirable:
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Internal and/or external auditing experience
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Lean Six Sigma qualification
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Understanding of ISO 9001, ISO 13485 and/or GxP
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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
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25 days holiday plus 8 bank holidays
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5% company pension contribution
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Death in Service life assurance (4x salary)
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Free onsite parking
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Company social events
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Electric Vehicle scheme
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Cycle to Work scheme
