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 DHF’s (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 pro ucts.
• 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 don’t 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 for a confidential chat. For a list of our current vacancies, please visit our website.
My contact details are:
Miss Rashida Khan
0113 225 1547
rashida@qualitystart.co.uk
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.
