About this role
About the Role Join Getinge's Maquet Cardiopulmonary GmbH in Rastatt as a Quality Engineer (m/w/d) – Product Development. You’ll contribute to the QA/Regulatory function supporting the R&D team to deliver regulatory-compliant, lifesaving medical devices. What You'll Do
- Support the R&D team in creating Technical File documents
- Review and approve technical documentation
- Support the test team in creating test methods
- Review and approve test plans and reports
- Stakeholder management within R&D projects
- Ensure implementation of normative/regulatory requirements in product development
- Review and approve Risk Management Files
- Assist in creating Periodic Safety Update Reports
- Assist R&D with creation of dFMEAs What We're Looking For
- Completed studies (MBA, M.Sc., Diplom, Spezialist) in health, engineering, natural sciences or business
- At least two years of experience in medical technology or a regulated environment
- At least one year of software development experience
- Ideally experience coordinating, participating, conducting and following up on internal and external audits
- Knowledge of ISO 13485 and 21 CFR Part 820
- Knowledge of project management basics
- Knowledge of MS Office and statistics software
- Strong analytical skills
- Very good German and English (spoken and written) Nice to Have
- Experience coordinating internal and external audits (internal/external audits coordination)
- Experience with DFMEAs (or related failure modes and effects analyses) Compensation & Benefits
- Metalltarif-based salary with 30 vacation days per year and additional attractive conditions
- Flexible, family-friendly working hours and mobile/work-from-anywhere options
- JobRad and corporate benefits
- Career opportunities in a renowned company
- Individual onboarding and training opportunities
- Modern workplace equipment