Senior Supplier Quality Engineer (SQE) – Medical Devices

HCL Technologies Limited; Berlin; On-site; EUR 90,000 - 120,000; Full time

Job summary

HCLTech in Germany is seeking an experienced Senior Supplier Quality Engineer to strengthen our Medical Devices team. You will own supplier quality, lead qualifications, audits, and CAPA, and ensure compliance with ISO 13485, EU MDR, and FDA where applicable.

Travel to supplier sites across Germany and Europe is required. German B2+ and professional English are essential, as is a strong background in MedTech quality systems.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Supplier quality engineering

Medical devices

Quality assurance

Regulatory compliance

Audit & CAPA

IQ/OQ/PQ

Process validation

Root cause analysis

Cross-functional collaboration

German B2+

Education

Bachelor's or Master's in Engineering

Tools

PFMEA

SPC

MSA

Job description

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.