Senior / Staff Quality Engineer, Product Transfer (m/f/d)

Reposted 10 Hours Ago
Be an Early Applicant
5 Locations
In-Office
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Senior/Staff Quality Engineer ensures seamless product transfers, driving quality excellence, cost optimization, and compliance with standards in a global setting.
Summary Generated by Built In
Work Flexibility: Hybrid or Onsite

As a Senior/Staff Quality Engineer (m/f/d) in Stryker’s Product Transfer Quality Engineering function, you will play a key role in ensuring seamless product transfers, driving quality excellence, cost optimization, and service improvements that directly benefit our customers.  

You will be an integral part of the QA Shared Services Product Transfer Team, collaborating across functions to support all quality-related activities and ensure compliance with both internal and external standards. 

 

What you will do 

  • Support all production transfers globally (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker)    

  • Review and approve Validation and Qualification documentation. 

  • Act as the QA point of contact during the Scoping, Planning, and Execution of the supplier transfer. 

  • Provide quality guidance related to relevant regulations, corporate standards, and procedures (e.g., FMEA, MSA, Validations). 

  • Identify potential quality risks during the transfer and propose effective solutions. 

  • Define QA strategies using a risk-based approach for FAI, inspection methods, and other key quality activities. 

 

What You Will Need 

Required Qualifications: 

  • Bachelor’s degree in Engineering, Sciences, or a related field. 

  • Minimum of 2 years’ experience in quality assurance and validation, ideally within the medical device or pharmaceutical industry. 

  • Strong knowledge of quality concepts, risk management tools (e.g., FMEA, PPAP), and regulatory standards (ISO 13485, FDA 21 CFR Part 820). 

  • Proficiency in English & German 

 

Preferred Qualifications: 

  • Experience in supplier quality and Quality Management Systems (QMS). 

  • Hands-on experience with product transfers in regulated environments. 

  • Excellent communication, presentation, and project management skills, with strong attention to detail. 

 

 

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 18 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.  

 

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 2 day a week on site at our location should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments. 

Travel Percentage: 10%

Top Skills

Fda 21 Cfr Part 820
Fmea
Iso 13485
Msa
Quality Management Systems (Qms)
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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