Quality Engineer
Contamac Ltd · Debden, England ·
Job Description Salary : £40,000 - £45,000 DOELocation : Saffron WaldenWorking pattern: Full-time, Monday to Friday, 09:0017:00About the roleContamac 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 doingAdminister and improve the Quality Management System in line with business needs, notified body requirements and relevant international and European standardsSupport QA activities across the business, including technical files, deviations, root cause investigations, process improvements, product information and proceduresWork with Operations to improve process controls, reduce scrap, support continuous improvement projects and maintain accurate process mapsConduct equipment qualifications and process validation, including protocol creationContribute to risk assessments, CAPAs, deviations and periodic reviewsLead root cause investigationsPerform internal audits to ISO 9001 and ISO 13485, including audit planning, non-conformance reporting, corrective action review and effectiveness checksRaise and track customer complaints, coordinate investigations, identify actions and monitor effectivenessManage site equipment calibration activities, including SOPs, records, approvals, registers and third-party contractorsSupport customer, supplier and regulatory audits, covering ISO 13485, FDA and other applicable standardsDevelop and maintain relevant areas of the QMS to ensure continued compliance, best practice and business relevanceAnalyse QA, production and R&D data and present findingsWrite, review and amend SOPs and technical documentationWork collaboratively across the organisation to improve product and process quality, supporting other QA projects and investigations as requiredWhat you'll bringEssential:2+ years' experience in a highly technical manufacturing environmentExperience with equipment qualification, process validation and protocol creationStrong technical written and spoken EnglishAbility to influence, build relationships and support efficient cross-functional processesClear communicator with good Microsoft Word and Excel skillsDesirable: Internal and/or external auditing experienceLean Six Sigma qualificationUnderstanding of ISO 9001, ISO 13485 and/or GxPBSc or equivalent in a relevant science or engineering subjectYou'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 offer25 days holiday plus 8 bank holidays5% company pension contributionDeath in Service life assurance (4x salary)Free onsite parkingCompany social eventsElectric Vehicle schemeCycle to Work schemeYou 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