You oversee quality activities for new products, ensuring compliance and effective collaboration across teams. Your role includes managing the product lifecycle and supporting quality deliverables for successful launches.
Anforderungen
- •Bachelor’s degree in Engineering or Life Sciences
- •2+ years in Quality or Manufacturing
- •Strong knowledge of risk management
- •Fluent in German and English
- •Strong communication and time management skills
- •Comfortable working independently and in a team
- •Experience with supplier quality and validation
- •Familiarity with FDA and ISO 13485
- •Exposure to design control and DHF documentation
- •Experience in cross-functional collaboration
Deine Aufgaben
- •Lead quality activities in New Product Introduction.
- •Support product lifecycle from concept to launch.
- •Manage risk, validation, and inspection planning.
- •Represent Quality in design reviews for compliance.
- •Collaborate with teams to standardize NPI processes.
- •Support supplier qualification and PPAP activities.
- •Validate external manufacturing processes.
- •Ensure quality deliverables like DHF and PFMEA.
- •Utilize statistical tools for inspection and production.
- •Communicate with teams and stakeholders for project success.
Original Beschreibung
# Senior Quality Engineer NPI (m/f/d)
**Baden-Württemberg, Freiburg Bötzinger Str 41** | **Full time**
Work Flexibility: Hybrid or Onsite
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, India, Ireland (Cork), Poland (Skawina), and US to ensure new products — from line extensions to novel Trauma & Extremities solutions — meet the highest standards of safety and compliance.
**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
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
**Additional information**
The position is initially **limited to 12 months**. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.
Travel Percentage: 20%