Qa software tester Jobs in Freiburg Im Breisgau

Work Flexibility : Hybrid or Onsite

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 English and 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.

Please note that the internal job title may differ from the ad title.

Travel Percentage : 10%