We are looking for an experienced Supplier Quality Engineer to join a leading regulated manufacturing organisation. Please note this is an initial 12-month subcontracting role.
You will support a diverse supplier base, managing supplier quality issues, change notifications, audits, validation activities, and continuous supplier performance improvement.
Key Responsibilities
- Manage Supplier Corrective Action Requests (SCARs) from initiation through verified closure
- Review Supplier Change Notifications and assess quality, regulatory and validation impacts
- Support supplier IQ/OQ/PQ validation, First Article Inspection (FAI) and PPAP-style activities
- Conduct desktop and onsite supplier audits and manage resulting actions
- Monitor supplier quality performance and support supplier scorecard reviews
- Maintain supplier quality records and agreements within the eQMS
- Support material review and supplier non-conformance activities
- Work with suppliers and internal stakeholders to drive corrective actions and quality improvements
Requirements
- Degree in Engineering, Science or related discipline
- 3+ years' Supplier Quality or Quality Engineering experience within a regulated industry
- Experience managing SCAR/CAPA and supplier non-conformances
- Experience supporting IQ/OQ/PQ process validation
- Working knowledge of ISO 13485 and FDA QMSR
- Understanding of risk management tools such as PFMEA
- Good statistical analysis skills, including SPC and capability studies
- Strong supplier and stakeholder management skills
- Experience with mechanical or moulding suppliers, Veeva QMS, Minitab, ISO 13485 Lead Auditor or ASQ CQE/CSQE certification would be advantageous
