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

Stryker Group; Freiburg im Breisgau; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global medical technology company is seeking a Senior Quality Engineer focused on Quality Assurance for Production Transfer in Freiburg. The successful candidate will oversee quality compliance during supplier transitions, leveraging expertise in risk management and regulatory standards. This role requires a Bachelor's degree and at least 2 years of relevant experience. Flexible working conditions are offered with some onsite presence required.

Leistungen

Flexible working hours

Opportunity for permanent position after 12-18 months

Qualifikationen

• Minimum 2 years of experience in quality assurance and validation in a regulated industry.
• Strong knowledge of quality concepts and regulatory standards.
• Fluent in English and German.

Aufgaben

• Support production transfers between suppliers.
• Act as the QA point of contact during transfers.
• Identify potential quality risks and propose solutions.

Kenntnisse

Quality Assurance expertise

Risk Management

Strong Communication

Technical Knowledge

Ausbildung

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

Tools

FMEA

MSA

Validation Systems

Jobbeschreibung

As a Senior Quality Engineer (m/f/d) with a focus on Quality Assurance for Production Transfer, you will play a key role in ensuring the successful transfer of production between two suppliers. This role combines technical quality expertise with strong communication and coordination skills to support compliance, operational excellence, and risk mitigation throughout the transfer process.

What you will do

• Support production transfers between suppliers, ensuring quality compliance throughout all phases.

• 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).

• Review and approve Validation and Qualification documentation.

• 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.

• Visit suppliers as needed (approx. once every 2 months) to support on-site QA activities.

What you will need
Required Qualifications:

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

• Minimum 2 years of experience in quality assurance and validation ideally in medical device or a similar field within a highly regulated industry (pharma, aerospace, food & beverage).

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

• Experience with Validation, Qualifications, and Quality Systems.

• Your Englishand German language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.

Preferred Qualifications:

• Experience in product transfers, particularly within regulated environments.

• Lean Six Sigma training or certification.

• Certification in Quality Management (CQE, CQA).

• Experience with QMS software and document control systems.

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 12 months, with high possibility to be extended 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 1 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.

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