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

Stryker; Emmingen-Liptingen; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A global medical technology company seeks a Senior/Staff Quality Engineer to support production transfers and ensure compliance with quality standards. The role involves collaborating across functions to drive quality excellence while managing quality risks. Applicants should have a Bachelor's degree in Engineering, at least 2 years of experience in quality assurance, and proficiency in both English and German. The position offers hybrid work flexibility, requiring some on-site presence.

Qualifikationen

• Minimum of 2 years' experience in quality assurance and validation.
• Strong knowledge of quality concepts and regulatory standards.
• Proficiency in English and German.

Aufgaben

• Support all production transfers globally.
• Review and approve Validation and Qualification documentation.
• Act as the QA point of contact during supplier transfers.

Kenntnisse

Quality assurance

Risk management

Communication skills

Project management

Ausbildung

Bachelor’s degree in Engineering or related field

Tools

FMEA

ISO 13485

FDA 21 CFR Part 820

Jobbeschreibung

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.

Y ou 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 1 8 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%