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

Stryker; Tuttlingen; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical technology company in Tuttlingen is seeking a Senior/Staff Quality Engineer to ensure seamless product transfers. The ideal candidate has a Bachelor's degree in Engineering or Sciences and at least 2 years of experience in quality assurance, particularly in the medical device industry. Responsibilities include supporting global production transfers and providing quality guidance on regulatory standards. This position offers flexible working arrangements while requiring regular on-site presence.

Qualifikationen

• Minimum of 2 years of experience in quality assurance and validation, ideally within the medical device or pharmaceutical industry.
• Strong knowledge of quality concepts and regulatory standards.
• Experience in supplier quality and Quality Management Systems (QMS).

Aufgaben

• Support production transfers globally across various supply chain scenarios.
• Review and approve validation and qualification documentation.
• Provide quality guidance aligned with regulations and corporate standards.

Kenntnisse

Quality assurance

Risk management

Regulatory standards knowledge (ISO 13485, FDA 21 CFR Part 820)

English proficiency

German proficiency

Ausbildung

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

Tools

FMEA

PPAP

Jobbeschreibung

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

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

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 related field.
• Minimum of 2 years of 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).
• ficiency in English and 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 option of being taken on in a permanent position.

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

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 150 million patients annually.