Supplier Quality Engineer / Auditor - Polymer & PPAP
Location: Southern Germany
Contract Length: 12-Month Contract
Start Date: November
Schedule: Full-time + regular travel to supplier sites
Language: German and English - fluent
Industry: Medical Devices / MedTech
Project Description
We are supporting a global medical device manufacturer as part of a major supplier quality and integration programme in Southern Germany.
The Supplier Quality team is looking for an experienced Supplier Quality Engineer / Auditor with a strong background in polymer/plastics manufacturing, supplier quality management and PPAP.
The successful candidate will be responsible for assessing and developing suppliers involved in the manufacture of medical devices, ensuring suppliers meet required quality, regulatory and manufacturing standards.
A strong understanding of PPAP, supplier qualification, process auditing, risk management and corrective action is essential. The role will involve regular supplier site visits across Southern Germany and close collaboration with Engineering, Quality, Procurement, Regulatory Affairs and suppliers.
Responsibilities
- Plan and conduct supplier quality audits across Southern Germany.
- Assess supplier manufacturing processes, quality systems, controls and documentation.
- Evaluate suppliers against applicable ISO 13485, ISO 9001 and medical device quality requirements.
- Apply strong knowledge of PPAP throughout supplier qualification and approval activities.
- Review and approve PPAP documentation, including process and product evidence, control plans and associated quality documentation.
- Conduct supplier process and manufacturing audits, identifying quality risks and improvement opportunities.
- Assess supplier capability and readiness for new products, components and process changes.
- Support supplier qualification, development and approval activities.
- Manage supplier NCRs, SCARs and CAPAs, ensuring corrective actions are implemented and effectively closed.
- Perform supplier risk assessments and recommend appropriate risk mitigation actions.
- Monitor supplier performance and quality KPIs.
- Support investigations into supplier-related quality issues and drive root-cause analysis.
- Review supplier process changes and assess their potential quality and regulatory impact.
- Develop strong working relationships with suppliers and internal stakeholders.
- Prepare detailed audit reports and communicate findings and recommendations to Quality leadership.
- Travel regularly to supplier sites across Southern Germany.
Qualifications & Experience
- Degree or equivalent qualification in Engineering, Polymer Engineering, Plastics Technology, Manufacturing, Quality, Materials Science or a related discipline.
- 5+ years' experience in Supplier Quality, Supplier Engineering or Quality Auditing, preferably within MedTech, automotive, manufacturing or another highly regulated industry.
- Strong practical experience working with polymers, plastics or polymer-based components/processes.
- Strong understanding and practical application of PPAP.
- Proven experience conducting supplier audits and process audits.
- Experience with supplier qualification, supplier development and supplier performance management.
- Strong understanding of CAPA, SCAR, NCR, root-cause analysis and corrective actions.
- Knowledge of ISO 13485 and/or ISO 9001.
- Experience with manufacturing processes and quality controls within polymer/plastics production.
- Experience with injection moulding, extrusion or other polymer manufacturing processes would be highly advantageous.
- Fluent German and English, written and spoken.
- Strong communication and stakeholder management skills.
- Willingness and ability to travel regularly to supplier sites across Southern Germany.
Desirable
- ISO 13485 or ISO 9001 Lead Auditor certification.
- Automotive VDA 6.3 auditing experience.
- Experience with medical device components or polymer-based medical products.
- Experience reviewing Supplier Quality Agreements.
- Experience with supplier development within an international manufacturing environment.
- Knowledge of APQP, FMEA, Control Plans, MSA and SPC.
- Experience working with injection moulding suppliers.
Key Requirements
Essential:
- German speaking
- Supplier Quality / Supplier Audit experience
- Strong PPAP knowledge
- Polymer / plastics experience
- Supplier process auditing
- CAPA / SCAR / NCR experience
- Quality management systems experience
- Willingness to travel across Southern Germany
Highly desirable:
- Medical Device / MedTech experience
- ISO 13485
- VDA 6.3
- ISO 13485/9001 Lead Auditor
- Injection moulding / polymer manufacturing experience
- Supplier Quality Agreement experience
About Korn Ferry
Korn Ferry unleashes potential in people, teams, and organizations. We work with our clients to design optimal organization structures, roles, and responsibilities. We help them hire the right people and advise them on how to reward and motivate their workforce while developing professionals as they navigate and advance their careers. To learn more, please visit Korn Ferry at www.Kornferry.com
