Quality Engineer

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 and manufacturing operations. The successful candidate will play a key role in ensuring products, processes and documentation comply with ISO 13485, FDA QMSR and customer requirements, whilst supporting continuous improvement and regulatory compliance across the business.

Your Responsibilities as Quality Engineer

• Support Quality Engineering and Quality Assurance activities across new product introduction, ensuring products and processes are designed with quality built in from the outset.
• Assist with equipment, process and software validation (IQ/OQ/PQ), working alongside Engineering to plan, execute and document validation activities.
• Maintain controlled quality documentation, including drawings, specifications, labels and approved supplier lists, whilst supporting risk management activities such as FMEA and hazard analysis.
• Support supplier quality, customer complaint investigations, CAPA activities, cleanroom compliance and internal/external audits to ensure ongoing regulatory and quality compliance.

Your Background as Quality Engineer

• Degree or HND qualified in Engineering, Quality, Life Sciences or a related discipline, with experience within a regulated manufacturing environment.
• Experience within Quality Engineering and/or Quality Assurance, ideally in the medical device industry or an ISO 13485-regulated environment.
• Knowledge of validation activities (IQ/OQ/PQ), CAPA, supplier quality, risk management and quality management systems including ISO 13485, ISO 9001 and FDA QMSR.
• Strong communication, analytical and problem-solving skills, with the ability to work cross-functionally across Engineering, Production and Quality teams.

Quality Engineer | Quality Assurance | Quality Engineering | Medical Devices | ISO 13485 | ISO 9001 | FDA QMSR | 21 CFR Part 820 | GMP | Validation | IQ | OQ | PQ | CAPA | Supplier Quality | Root Cause Analysis | FMEA | Risk Management | Cleanroom | ISO 14644 | Complaint Handling | Change Control | Internal Audits | Regulatory Compliance | Continuous Improvement | Manufacturing Quality

Job ID: 111930