As a Senior Quality Engineer (m/f/d) New Product Introduction, you’ll help bring innovative medical technologies to market by driving quality across the full product lifecycle. Based in Freiburg, you’ll collaborate with global teams in Germany, Puerto Rico, Poland (Skawina), and Mexico (Tijuana) to ensure new products — from line extensions to novel CMF 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:

Bachelor’s 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 - 19,5 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. 

Please note that the internal job title may differ from the ad title.