A fast-growing, highly regulated technology-driven organization operating in the healthcare and life sciences sector. The company is focused on developing innovative, next-generation solutions that improve patient outcomes and transform clinical practice. As the organization scales and advances toward critical regulatory and commercial milestones, it is seeking an experienced quality professional to strengthen and manage its supplier quality and compliance activities.
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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.
Halian Group
With over 28 years of experience, we have come to understand that innovation is the only way to provide agile, practical solutions that transform businesses and careers.
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At Halian, we recognize that diversity, equity, and inclusion (DEI) are essential to building high-performing teams for our clients. We are committed to connecting organizations with top talent from all backgrounds, ensuring that every individual feels valued, respected, and empowered to contribute their unique perspectives. We encourage applications from all qualified candidates, regardless of race, gender, disability, or any other characteristic that makes them unique. xwzovoh By fostering diverse and inclusive workplaces, we help our clients drive innovation, enhance collaboration, and better reflect the communities they serve.