QA Manager (m/f/d)

We are searching for intelligent and innovative employees for our Automotive customers as Mercedes-Benz, Porsche and Robert Bosch. If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application.

Your tasks:

• Execute and guide teams through Design Control requirements
• Support preclinical and clinical planning and readiness
• Effectively manage project timelines as defined by department, project team and corporate objectives
• Guide and provide input to risk management activities throughout all stages of the device development process
• Support R&D related audits, both internal and external; support R&D related SOP creation and maintenance; support R&D related NCRs/CAPAs
• Support internal and external audit activities
• Manage development Usability process

Your profile:

• Abgeschlossenes Studium
• Min. 8 years relevant medical device development experience including Quality experience
• Certifications – ASQ Certified Quality Manager; Certified Quality Engineer or Certified Quality Engineer – is a plus
• Knowledge of regulatory requirements and standarts for a medical device arganization (i.e. 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines.)
• Experience with quality compliance in clinical, non-clinical and manufacturing issues
• Experience with FDA, European agency regulations, cGMP regulations and Quality Management software is highly preffered
• Proficient in all MS Office
• Good German and English language skills (spoken and written)

You can expect …

• Experience in exciting and international projects
• Continuous salary development
• Da Vinci Corporate Benefits
• On-the-job training and language courses
• Appreciation, motivation and commitment

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!