Base: 62,500 - 97,865 euro; bonus/equity: not spec...
On-site (3-4 days per week)
Quality system regulation
Iso 13485
Iso 14971
Johnson & Johnson is seeking a Design Quality Engineer II in Aachen, Germany, to lead New Product Development activities focused on medical devices for chronic heart failure patients. The role demands strong communication skills and the ability to work in a dynamic, team-oriented environment while ensuring compliance with quality systems and regulations
Job Summary
Support New Product Development projects Risk Management Deliverables.
Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation.
Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Design Quality Engineer II in Aachen, Germany, to lead New Product Development activities focused on medical devices for chronic heart failure patients. The role demands strong communication skills and the ability to work in a dynamic, team-oriented environment while ensuring compliance with quality systems and regulations.
Salary
Base: 62,500 - 97,865 Euro; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Quality System Regulation
ISO 13485
ISO 14971
21 CFR Part 820
New Product Development
Risk Management
Nice-to-have
Process development studies
Statistical analysis in Minitab
Multidisciplinary projects
CAPA activities
3rd party audits
Blueprint reading/literacy
Key Requirements
Bachelor's degree in engineering or scientific discipline
1+ years of work experience in a highly regulated industry