Quality engineer
Location: Saffron Walden, Essex Job type: Permanent, full time Salary: £40,000 - £45,000 per annum, dependent on experience
The role
We are recruiting a Quality Engineer on behalf of a well-established, manufacturing business based in Saffron Walden. Joining the Quality Assurance team, you will play a key role in ensuring the business meets its regulatory, compliance, and strategic quality objectives. This is a broad and varied role covering everything from equipment qualification and process validation through to internal audits, CAPAs, and customer complaint management. The role would suit a proactive, adaptable quality professional with strong communication skills and a positive, solutions-focused approach.
Main responsibilities
- Support QA activities across the business including technical files, deviations, root cause investigations, process improvements, and procedures
- Conduct equipment qualifications and software and process validations, including protocol creation
- Perform internal audits to ISO 9001 and ISO 13485, including audit planning, non-conformance reporting, corrective action review, and effectiveness checks
- Contribute to risk assessments, CAPAs, deviations, and periodic reviews
- 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 ISO 13485, FDA, and other applicable standards
- Work with operations to improve process controls, reduce scrap, and support continuous improvement projects
- Develop and maintain relevant areas of the QMS to ensure continued compliance and best practice
- Analyse QA, production, and R&D data and present findings
- Write, review, and amend SOPs and technical documentation
Skills/experience
Essential:
- Two or more years of experience in a highly technical manufacturing environment
- Experience with equipment qualification, software and 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
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 discipline
Salary & working hours
- Salary: £40,000 - £45,000 per annum, dependent on experience
- Hours: Monday to Friday, 09:00 - 17:00
Benefits
- 25 days annual leave plus eight bank holidays
- Pension scheme with 5% company contribution
- Death in service life assurance at four times salary
- Free on-site parking
- Electric vehicle scheme
- Cycle to work scheme
- Company social events
If the position of Quality Engineer is of interest, please click Apply. We aim to respond to all applicants; however, if you haven't heard from us within 10 days, please assume your application has been unsuccessful on this occasion.
If you have any questions regarding this Quality Engineer role, please don't hesitate to contact our office.
INDENGINEERING