Senior Quality Engineer (m/f/d) New Product Introduction (part-time)

Stryker Group; Freiburg im Breisgau; Hybrid; EUR 55.000 - 75.000; Teilzeit

Zusammenfassung

A leading global company in medical technology is seeking a Senior Quality Engineer for New Product Introduction. This role involves leading quality activities, ensuring compliance with standards, and collaborating with cross-functional teams. The position is part-time, allowing for flexible working hours while maintaining presence on-site in Freiburg. Ideal candidates will have a degree in Engineering or Life Sciences, with strong knowledge of quality processes in the medical device industry.

Qualifikationen

• 2+ years in Quality or Manufacturing within Medical Devices or Pharma.
• Fluent in German and English.
• Comfortable working independently and in a team environment.

Aufgaben

• Lead quality activities in New Product Introduction (NPI).
• Support full product lifecycle from concept to commercial launch.
• Collaborate with cross-functional teams across regions.

Kenntnisse

Risk Management

Statistics

Strong Communication

Time Management

Ausbildung

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Jobbeschreibung

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 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:

• 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.

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