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

PowerToFly; Schönkirchen; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global leader in medical technologies is seeking a Senior Quality Engineer in Schönkirchen, Germany. The role involves supporting production transfers globally, reviewing quality documentation, and acting as the QA point of contact during supplier transfers. Candidates must have a Bachelor’s degree in Engineering or related fields, with at least 2 years of experience in quality assurance, ideally in the medical device industry. Proficiency in both English and German is required. Flexible working hours and a possibility of a permanent position are offered.

Leistungen

Flexible working hours

Partial home office options

Qualifikationen

• Minimum of 2 years’ experience in quality assurance and validation, ideally within the medical device or pharmaceutical industry.
• Strong knowledge of regulatory standards.
• Excellent communication and presentation skills.

Aufgaben

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

Kenntnisse

Quality concepts

Risk management tools (FMEA, PPAP)

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

Proficiency in English

Proficiency in German

Ausbildung

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

Jobbeschreibung

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.

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.