Quality Engineer – Medical Devices (ISO 13485)

Contamac; Saffron Walden; On-site; GBP 40,000 - 45,000; Full time

Benefits offered by this job

25 days holiday

Company pension 5%

Death in Service life assurance (4x)

Free onsite parking

Company social events

Electric Vehicle scheme

Cycle to Work scheme

Job summary

Contamac, based in Saffron Walden, is seeking a Quality Engineer to join the Quality Assurance team. The role focuses on maintaining regulatory compliance, improving the QMS, and supporting QA activities across the business.

You will work with Operations to enhance process controls, lead investigations, and contribute to continual improvement initiatives in a highly technical manufacturing environment. 2+ years' experience and strong English skills are essential.

Qualifications

• 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 cross‑functional processes.
• Clear communicator with good Microsoft Word and Excel skills.

Responsibilities

• 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.

Skills

Equipment qualification

Process validation

Protocol creation

English proficiency

Cross-functional influence

MS Word

MS Excel

Education

BSc or equivalent in a relevant science or engineering subject

Tools

MS Word

MS Excel

Job description

Contamac, based in Saffron Walden, is seeking a Quality Engineer to join the Quality Assurance team. The role focuses on maintaining regulatory compliance, improving the QMS, and supporting QA activities across the business.

You will work with Operations to enhance process controls, lead investigations, and contribute to continual improvement initiatives in a highly technical manufacturing environment. 2+ years' experience and strong English skills are essential.