Supplier Quality Engineer

Responsibilities

• Supplier Quality Management: Own and manage the supplier quality program, including onboarding, evaluation, performance monitoring, and ongoing compliance.
• Supplier Auditing: Plan and conduct supplier audits (remote and on-site), including international travel where required.
• Corrective & Preventive Actions: Lead supplier corrective action requests (SCARs), manage CAPAs, and ensure timely and effective resolution of quality issues.
• Cross-Functional Collaboration: Work closely with R&D, Manufacturing, and Engineering teams to support supplier selection, design-for-manufacture activities, and process improvements.
• Risk Management: Identify and mitigate supplier-related risks through audits, validation activities, and continuous monitoring.
• Design & Manufacturing Support: Contribute quality engineering input throughout product development, including design reviews, tolerances, specifications, and manufacturability assessments.
• Regulatory & Compliance Support: Ensure supplier processes comply with applicable regulatory and quality standards and support internal and external audits and inspections.
• Process Validation & Capability: Support supplier process validations (IQ/OQ/PQ) and capability studies (e.g., Cp/Cpk) to ensure consistent quality output.
• Reporting & Insights: Track quality metrics and supplier performance trends, providing clear and actionable insights to senior stakeholders.
• On-Site Oversight: Where necessary, work temporarily at supplier facilities to oversee quality activities and resolve critical issues.

Qualifications and Skills

• Education: Bachelor’s degree in Engineering or a related technical discipline.
• Supplier Quality Experience: Proven experience managing supplier quality within a highly regulated industry (e.g., medical devices, healthcare, aerospace, defence).
• Auditing Expertise: Strong background in external supplier auditing and quality agreement management.
• Quality Systems Knowledge: Solid understanding of quality management systems, regulatory requirements, and manufacturing processes.
• Technical Interpretation: Ability to read and interpret engineering drawings, tolerances, and technical specifications.
• Problem-Solving: Demonstrated experience in root cause analysis, CAPA management, and non-conformance handling.
• Process & Manufacturing Insight: Knowledge of manufacturing processes, validation, and supplier capability assessments.
• Communication Skills: Clear, confident communicator able to work effectively with internal teams and external suppliers.
• Flexibility & Travel: Willingness to travel regularly within the UK and internationally.
• Desirable Skills: Lead Auditor certification, Six Sigma qualification, and experience with regulated manufacturing environments.

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