Quality Engineer Medical Device jobs

We are recruiting for a Quality and Validation Engineer to join the Quality Assurance Team and help ensure Contamac and its subsidiaries meet regulatory, compliance and strategic objectives.

We are looking for a proactive, adaptable team player with a positive problem-solving approach, strong communication skills and the ability to work collaboratively across the business.

Contamac manufacture polymers for contact and intraocular lens materials (used in cataract surgery) and are based in Saffron Walden.

Knowledge & Experience

Essential

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

Advantageous

• 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.

Role Function

To 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, software, and process validation, including protocol creation.
• Contribute to risk assessments, CAPAs, deviations and periodic reviews.
• 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, including matters relating to 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.

Person Specification

• Professional, positive and team-focused.
• Self-motivated, resilient, flexible and adaptable.
• Confident decision-maker with excellent attention to detail.
• Strong verbal and written communication skills.
• Proactive self-starter with a can-do approach.

Benefits

• Salary Range: £40,000 - £45,000 DOE
• Hours: 09:00-17:00 Monday to Friday
• Holidays: 25 days + 8 bank holidays
• Pension: 5% company contribution
• DIS: Death in Service Life Assurance = 4 x salary
• Parking: Free, onsite
• Company Social Events
• Electric Vehicle Scheme
• Cycle to Work Scheme

Job Types: Permanent, Full-time

Pay: £40,000.00-£45,000.00 per year

Benefits:

• Company events
• Company pension
• Cycle to work scheme
• Free parking
• Life insurance
• On-site parking
• Referral programme

Application question(s):

• Are you within a 60 minute radius to commute daily to our Saffron Walden, CB11 3AU site?

Experience:

• process validation and equipment qualification: 1 year (required)

Work authorisation:

• United Kingdom (required)

Work Location: In person