Walker Cole International
Quality Engineer
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Quality Engineer – Quality Assurance
About the Role
A leading medical device manufacturer is seeking a Quality Engineer to join its Quality team in Suffolk, UK.
This is an exciting opportunity to support Quality Engineering and Quality Assurance activities across:
- New product introduction
- Validation
- Supplier quality
- Manufacturing operations
The successful candidate will play a key role in ensuring products, processes, and documentation comply with:
- ISO 13485
- FDA QMSR
- Customer requirements
They will also support continuously improving and maintaining industry-compliant operational standards.
Responsibilities
Core Quality Assurance & Engineering Duties
- Support Quality Engineering & Assurance across new product development, ensuring quality-by-design principles are embedded from the outset.
- Assist in equipment, process, and software validation (including IQ/OQ/PQ), collaborating with Engineering teams to:
- Plan validation activities
- Execute tests
- Comply with documentation standards
- Maintain controlled quality documentation, including:
- Product drawings & specifications
- Labelling compliance
- Approved supplier lists
- Support risk management activities, including:
- Conducting FMEAs (Failure Mode & Effects Analysis)
- Performing hazard analyses
- Contribute to supplier quality, ensuring supplier compliance with:
- ISO 13485, GMP, and FDA regulations
- Lead or assist in:
- Customer complaint investigations
- CAPA (Corrective and Preventive Action) processes
- Cleanroom compliance reviews
- Internal and external audits
- Regulatory compliance maintenance
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Requirements & Skills
Technical & Regulatory Knowledge
- Hold a degree (or HND) in Engineering, Quality, Life Sciences, or a related field.
- Extensive experience in a regulated manufacturing environment, ideally within:
- Medical device quality engineering/assurance
- ISO 13485-compliant operations
- FDA-regulated contexts (21 CFR Part 820)
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Proven Expertise In:
- Validation methodologies (IQ, OQ, PQ)
- CAPA processes
- Supplier quality management
- Risk management (FMEA, hazard analysis, etc.)
- Certification with adherence to:
- ISO 13485
- ISO 9001
- FDA QMSR
Soft Skills & Work Culture
- Strong ability to collaborate cross-functionally with:
- Engineering
- Production
- Quality stakeholder groups
- Exceptional analytical thinking, problem-solving, and communication skills.
- Commercially aware with an insightful, process-driven mindset to drive continuous improvement.
Key tags: Quality Engineer | Quality Assurance | Medical Devices | ISO 13485 | ISO 9001 | FDA QMSR | Validation IQ | OQ | PQ | Risk Management | Cleanroom 14644
Job ID: 111930
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