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

Stryker Leibinger GmbH & Co. KG; Schönkirchen; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A leading medical technology company is seeking a Senior / Staff Quality Engineer to ensure seamless product transfers and drive quality excellence. The position involves supporting production transfers globally, reviewing validation documentation, and providing quality guidance in a regulated environment. Candidates should possess a Bachelor's degree in a related field, with a minimum of 2 years’ experience in quality assurance, proficient in English and German. The role offers hybrid working options with a travel percentage of 10%.

Qualifikationen

• Minimum of 2 years’ experience in quality assurance and validation, ideally within the medical device or pharmaceutical industry.
• Proficiency in English & German.
• Hands-on experience with product transfers in regulated environments.

Aufgaben

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

Kenntnisse

Quality Assurance

Risk Management

Communication

Project Management

Attention to Detail

Ausbildung

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

Tools

Quality Management Systems (QMS)

FMEA

PPAP

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.

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.

Responsibilities

• 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

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
• 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

Additional Information

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.

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 days a week on site at our location should always be given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Travel Percentage: 10%