At a Glance
- Tasks: Support quality assurance and engineering for innovative medical devices.
- Company: Leading medical device manufacturer in Suffolk, UK.
- Benefits: Competitive salary, career growth, and a chance to make a difference.
- Other info: Dynamic role with opportunities for continuous improvement and regulatory compliance.
- Why this job: Join a team ensuring high-quality products that save lives.
- Qualifications: Degree in Engineering or related field; experience in regulated environments preferred.
The predicted salary is between 40000 - 45000 £ per year.
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 in Suffolk employer: Walker Cole International
As a leading medical device manufacturer based in Suffolk, we pride ourselves on fostering a collaborative and innovative work environment where quality is at the forefront of everything we do. Our commitment to employee development is reflected in our comprehensive training programmes and opportunities for career advancement, ensuring that our Quality Engineers are equipped with the skills needed to excel in their roles. Join us and be part of a team dedicated to making a meaningful impact in the healthcare industry while enjoying a supportive culture that values continuous improvement and regulatory excellence.
