Planet Pharma
Quality Engineer
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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 categories
- Review and approve process validation documentation including FAT, SAT, IQ, OQ and PQ activities
- Evaluate and approve PFMEAs and Control Plans
- Support transfer of design requirements into manufacturing environments
- Partner closely with external suppliers, CMOs and cross-functional engineering teams
- Investigate manufacturing and supplier-related non-conformances
- Support root cause analysis and corrective action implementation
- Review and assess change control activities
- Ensure manufacturing processes are capable of meeting product quality requirements
- Contribute to manufacturing readiness and commercialisation activities
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What We're Looking For
- Degree qualified in Mechanical, Manufacturing, Process or related Engineering discipline
- Strong experience within the Medical Device industry
- Background as a Quality Engineer, Supplier Quality Engineer, Manufacturing Quality Engineer, NPI Engineer or Process Validation Engineer
- Extensive experience of process validation and qualification activities
- Strong understanding of PFMEA and Control Plans
- Experience supporting external suppliers and contract manufacturers
- Familiarity with non-conformance investigations and root cause analysis tools
- Understanding of design controls and change management processes
- Ability to interpret technical drawings, specifications and validation documentation
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Highly Desirable
- Injection moulding manufacturing experience
- Automated assembly line qualification experience
- Supplier quality management experience
- Test method validation, MSA and GR&R knowledge
- Experience working within ISO 13485 environments
- Combination product or complex medical device experience
Working Pattern
- Hybrid working (2 days onsite)
- Occasional travel to European manufacturing partners and suppliers
- Immediate 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.
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