Project Quality Engineer

Project Quality Engineer (12 Month Contract) About the Opportunity We're supporting a highly innovative international pharmaceutical and medical technology organisation that is advancing a complex combination product through late-stage development towards commercialisation. As part of a major manufacturing readiness programme, they are seeking an experienced Project Quality Engineer to support supplier qualification, process validation, manufacturing quality activities, and external partner oversight across a sophisticated multi-component medical device platform. This is an excellent opportunity to join a fast-paced development programme where your work will directly contribute to successful product launch activities. Key Responsibilities Support qualification of supplier manufacturing processes across multiple component categoriesReview and approve process validation documentation including FAT, SAT, IQ, OQ and PQ activitiesEvaluate and approve PFMEAs and Control PlansSupport transfer of design requirements into manufacturing environmentsPartner closely with external suppliers, CMOs and cross-functional engineering teamsInvestigate manufacturing and supplier-related non-conformancesSupport root cause analysis and corrective action implementationReview and assess change control activitiesEnsure manufacturing processes are capable of meeting product quality requirementsContribute to manufacturing readiness and commercialisation activities What We're Looking For Degree qualified in Mechanical, Manufacturing, Process or related Engineering disciplineStrong experience within the Medical Device industryBackground as a Quality Engineer, Supplier Quality Engineer, Manufacturing Quality Engineer, NPI Engineer or Process Validation EngineerExtensive experience of process validation and qualification activitiesStrong understanding of PFMEA and Control PlansExperience supporting external suppliers and contract manufacturersFamiliarity with non-conformance investigations and root cause analysis toolsUnderstanding of design controls and change management processesAbility to interpret technical drawings, specifications and validation documentation Highly Desirable Injection moulding manufacturing experienceAutomated assembly line qualification experienceSupplier quality management experienceTest method validation, MSA and GR&R knowledgeExperience working within ISO 13485 environmentsCombination product or complex medical device experience Working Pattern Hybrid working (2 days onsite)Occasional travel to European manufacturing partners and suppliersImmediate availability preferred, although short notice periods will be considered Interested? This is a fantastic opportunity for a hands-on Quality Engineer who enjoys working closely with manufacturing processes, suppliers and product development teams rather than traditional QMS-focused quality roles. Apply now for a confidential discussion.