Quality Engineer

Project Quality Engineer | Medical Device Manufacturing | 12-Month Contract

Are you a Medical Device Quality, Validation or Manufacturing Engineer with a strong track record in manufacturing process validation and supplier oversight ?

We're supporting an innovative medical technology programme entering a critical phase of supplier qualification and manufacturing readiness and are looking for an experienced engineer to play a key role in bringing a complex product to commercial manufacture.

What You'll Be Doing

• Support qualification of external supplier manufacturing processes.
• Review and approve manufacturing validation documentation including FAT, SAT, IQ, OQ and PQ .
• Drive supplier quality activities across Contract Manufacturers (CMOs) and external vendors.
• Review and challenge PFMEAs, Control Plans, MSA and GR&R studies .
• Support manufacturing readiness and industrialisation activities.
• Investigate supplier and manufacturing non-conformances, driving robust corrective actions.
• Partner with Quality, NPI, Manufacturing and Supplier teams to ensure product and process risks are appropriately identified and controlled.
• Support change control activities and ensure validated processes remain compliant throughout the product lifecycle.

What We're Looking For

• Medical device industry experience
• Strong experience with manufacturing process validation
• Hands-on knowledge of IQ/OQ/PQ
• Experience reviewing or developing PFMEAs and Control Plans
• Experience working directly with CMOs, CDMOs and external suppliers
• Supplier qualification and supplier quality oversight experience
• Root cause investigation, CAPA and non-conformance management experience
• Understanding of manufacturing processes such as injection moulding, automated assembly, machining or related component manufacturing processes
• Experience supporting NPI, industrialisation, design transfer or manufacturing readiness activities

Desirable

• ISO 13485 environment
• Combination product or medical device manufacturing experience
• MSA, GR&R and statistical process capability experience
• ASQ CQE or equivalent quality qualifications