At a Glance
- Tasks: Ensure quality standards in manufacturing and improve processes for better compliance.
- Company: Join a leading manufacturer of polymers for medical devices in Saffron Walden.
- Benefits: Enjoy 25 days holiday, pension contributions, and social events.
- Other info: Opportunities for professional growth and a supportive work culture.
- Why this job: Make a real impact on product quality in a dynamic team environment.
- Qualifications: 2+ years in a technical manufacturing role with strong communication skills.
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:
- 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.
Quality Engineer employer: Contamac Ltd
Contamac is an exceptional employer located in Saffron Walden, offering a supportive work culture that prioritises employee growth and development. With a comprehensive benefits package including 25 days of holiday, a generous pension contribution, and various wellness initiatives, employees are encouraged to thrive both personally and professionally. The collaborative environment fosters innovation and continuous improvement, making it an ideal place for Quality Engineers looking to make a meaningful impact in the medical device industry.
