Design Quality Engineer

iO Associates - UK/EU; München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A high-growth MedTech start-up in South Germany is seeking an Advanced Design Quality Engineer to ensure regulatory compliance throughout the product lifecycle. The role involves collaboration with R&D, Regulatory Affairs, and Manufacturing teams while focusing on quality management and risk assessment.

Qualifikationen

• 4+ years of quality experience in medical devices.
• Strong knowledge of international standards and regulatory frameworks.

Aufgaben

• Ensure compliance with ISO standards and FDA QSR.
• Lead risk management and support design verification and validation.
• Contribute to technical documentation and design reviews.

Kenntnisse

Quality Management

Regulatory Compliance

Risk Management

Cross-functional Collaboration

Ausbildung

Engineering or related field

Jobbeschreibung

Direct message the job poster from iO Associates - UK/EU

Helping Health & MedTech Companies Secure Top Regulatory Affairs and Quality Management Talent in South Germany

Advanced Design Quality Engineer - MedTech Start-up
Permanent | Hybrid | Start ASAP

I'm supporting a high-growth MedTech start-up developing advanced imaging technologies that combine hardware, software, and AI to address critical clinical needs.

They're looking for a permanent Advanced Design Quality Engineer to ensure regulatory compliance across the full product lifecycle and support R&D, Regulatory Affairs, and Manufacturing teams.

Key Responsibilities:

• Ensure compliance with ISO 13485, 14971, 62304, 62366, 60601, and FDA QSR
• Lead risk management (FMEA, hazard analysis) and support design V&V
• Contribute to technical documentation, labelling, and design reviews
• Support CAPA, change control, internal audits, and software/electrical safety compliance
• Provide input on AI and cybersecurity considerations for medical devices

Ideal Profile:

• 4+ years of quality experience in medical devices
• Strong knowledge of international standards and regulatory frameworks
• Experienced in V&V, risk tools, and cross-functional collaboration
• Background in engineering, quality, or a related field

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Health Care Provider, Information Technology, and Manufacturing
• Medical Equipment Manufacturing