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Medical Device / Plastics / Injection Moulding Quality Engineer
Hertfordshire (Full Time, Permanent) £35,000 - £45,000 / Year
Medical Device / Plastics / Injection Moulding Quality Engineer - Hertfordshire, South East
Medical Device / Plastics / Injection Moulding Quality Engineer Hertfordshire
Opportunity:
Your role as a Medical Device / Plastics / Injection Moulding Quality Assurance Engineer based in Hertfordshire will involve working with the VP, Quality and QA Manager to provide a Quality Engineering capability for my client. You will establish specifications and acceptance criteria for moulded components/ packaging and supplier development activities for new and existing products, together with process improvement activities using statistical /quality tools in compliance with ISO 13485 and FDA (21 CFR) part 820 requirements.
Duties include:
Establish and maintain specifications, test methods and acceptance criteria for moulded components, and critical packaging items. Risk management activities and the development of master quality plans. Supplier quality development. Auditing. Quality assurance and change control. Quality engineering support to new product development (NPD). Oversee all activities related to design control and maintenance of DHFs (Design History Files) for new and existing devices. Responsible for the maintenance of the design history files. Validating clean room equipment and process validation activities, including preparation of protocols, execution and reporting. Continuous improvement projects.
This is a full time permanent role.
Skills:
To apply for this role you must have the following:
Degree or equivalent qualification in an engineering, scientific or technical subject. Experience in the Quality Engineering of medical technology, plastics or injection moulding. Experience working to ISO 13485 and FDA (21 CFR) part 820 compliant systems. Ideally Design Control and risk management (EN ISO 14971) for Class III medical device products. Experience with developing Design History Files for devices. Experience in vendor audit and vendor development. Able to review data and monitor data trends. Investigational and problem solving skills root cause analysis. Quality Engineering tools and concepts such as dFMEAs, pFMEAs, 8D, 5 Why, SPC, Minitab, Six Sigma, Lean etc. GMP and Quality Systems.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call (Apply online only) for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
