Shape Quality. Drive Innovation. Make an Impact in MedTech.
At HCLTech, we're looking for an experienced Senior Supplier Quality Engineer (SQE) to strengthen our Medical Devices team in Germany.
Take ownership of supplier quality, drive process excellence, and ensure the highest standards of quality and regulatory compliance across our European supplier network.
What You'll Do
- Lead supplier qualification, audits, and performance improvement initiatives.
- Own process validation activities, including IQ/OQ/PQ, risk assessments, and compliance.
- Drive CAPA, root cause analysis, and continuous improvement across manufacturing processes.
- Review PFMEA, PPAP, FAIR, Control Plans, and supplier change management.
- Collaborate with Quality, Engineering, Manufacturing, and Regulatory Affairs teams.
- Ensure compliance with ISO 13485, ISO 14971, EU MDR, and FDA requirements.
What We’re Looking For
- 8–10 years of experience in Supplier Quality Engineering, Manufacturing Quality, or Quality Assurance.
- Strong background in Medical Devices / MedTech and regulated manufacturing.
- Hands-on expertise in IQ/OQ/PQ, CAPA, SPC, MSA, PFMEA, and supplier audits.
- Solid knowledge of medical device quality standards and regulatory requirements.
- Bachelor's or Master's degree in Engineering or a related field.
- German B2+ and professional English.
- Willingness to travel to supplier sites across Germany and Europe.
Nice to Have: ISO 13485 Lead Auditor, Six Sigma, ASQ CQE/CQA, or VDA 6.3 certification.
Travel: Within Germany and Europe to supplier locations
HCLTech is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified candidates regardless of gender, age, disability, ethnic origin, religion, sexual orientation, or other legally protected characteristics.
Personal data submitted during recruitment will be processed in accordance with applicable data protection laws, including the GDPR, and HCLTech's recruitment privacy policy.
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Senior Supplier Quality Engineer (SQE) – Medical Devices in Berlin Arbeitgeber: HCLTech
Als Arbeitgeber bietet unser Unternehmen eine dynamische und unterstützende Arbeitsumgebung, die auf kontinuierliche Verbesserung und Innovation ausgerichtet ist. Wir fördern eine leistungsorientierte Unternehmenskultur, die nicht nur die berufliche Weiterentwicklung unserer Mitarbeiter unterstützt, sondern auch ein starkes Engagement für Teamarbeit und Kundenbeziehungen betont. Mit einem Standort im Raum Frankfurt/Rhein-Main profitieren unsere Mitarbeiter von einer zentralen Lage in einer der wirtschaftlich stärksten Regionen Deutschlands, die zahlreiche Möglichkeiten für Networking und persönliche Entwicklung bietet.
