Senior Quality Engineer (m/f/d) New Product Introduction (part-time)
Senior Quality Engineer (m/f/d) New Product Introduction (part-time)
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Job Description
As a Senior Quality Engineer (m/f/d) New Product Introduction youll help bring innovative medical technologies to market by driving quality across the full product lifecycle. Based in Freiburg youll collaborate with global teams in Germany Puerto Rico Poland (Skawina) and Mexico (Tijuana) to ensure new products from line extensions to novelCMF solutions meet the highest standards of safety and compliance.
This is a 50% role and a unique opportunity to shape how life-changing devices are developed and launched.
What will you do:
Lead quality activities in New Product Introduction (NPI) with a focus on both line extensions and new-to-market devices
Support full product lifecycle from concept to commercial launch including risk management validation and inspection planning
Represent Quality during design reviews ensuring compliance with FDA ISO 13485 and internal Stryker processes
Collaborate with cross-functional teams across regions to standardize NPI processes and deliverables
Support supplier qualification and PPAP activities and support validation of external manufacturing processes
Ensure robustness of quality deliverables including DHF PFMEA and CAPA input as needed
Utilize statistical tools to develop efficient scalable inspection and production quality systems
Communicate clearly with internal teams suppliers and stakeholders to ensure timely and high-quality project outcomes
What will you need:
Required:
Bachelors degree in Engineering Life Sciences or related technical field
2 years in Quality or Manufacturing within Medical Devices or Pharma (or other highly regulated industry). The seniority of the role may be adjusted based on your experience and qualifications
Strong knowledge of risk management PFMEA and statistics
Fluent in German and English
Strong communication initiative and time management skills
Comfortable working both independently and in a team environment
Preferred:
Experience with supplier quality PPAP validation and supplier audits
Familiarity with FDA ISO 13485 and NC/CAPA processes
Exposure to design control and DHF documentation
Experience in cross-functional collaboration across global teams
Additional information
The position is a permanent part-time role (50% FTE - 195 hours).
Thanks to our flexible working hours model you will have the opportunity to work partially from the home office. However a regular presence on site of 3 days a week at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
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Travel Percentage: 10%Required Experience:
Senior IC
Employment Type
Part-Time
