For one of our clients, a world leader in in-vitro diagnostics, we are currently looking for a Product Quality Engineer.
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General Information:
- Start date: 01.11.2026
- Latest Start Date: 01.01.2027
- Planned duration: 12 months with the possibility of extension (depending on the project extension and approved budget)
- Workplace: Red Cross
- Workload: 80-100%
- Home Office: possible
- Team: Project teams 5-10 ; Department 19 people
- Department: DOEBA , EM M-SAT
- Working hours: Standard
- Travel: Possible up to 10%
About the job:
External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.
As a Product Quality Engineer you are responsible for the planning and state of the art measurement of the technical test specifications. This role assures that the products are tested compliant to the regulations, including statistical sampling plan and test procedures. The Product Quality Engineer provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.
The Perfect Candidate:
Has a M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with a high degree of subject matter expertise and at least 3 years of relevant work experience in a GMP regulated, producing company.
Tasks & responsibilities:
- Transfer product specification into test equipment requirements (URS)
- Define and develop test equipment
- Define acceptance criteria for test equipment
- Accountable for creation of test plan
- Implementation of test planning at supplier and RDI
- Define sample size for in-process control (IPC), product release testing and incoming goods inspection
- Conduct internal and supplier trainings regarding product quality inspection
- Accountable for test equipment qualification, test method validation, including correlation studies to RDI test equipment
- Technical Q&V documentation review at supplier regarding test equipment qualification, test method validation
- Responsible for review of first article inspection (FAI) incl. verification of the tolerance situation
- Technical assessment of changes of test equipment and test planning
Must Haves:
- M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
- 3+ years of relevant work experience in a GMP regulated, producing company
- Experience in IVD product manufacturing and testing
- Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
- Experienced in test equipment qualification and test method validation
- In-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.
- Ability to think strategically and systemically, willingness to try new ideas and participate in changes
- Self-motivated, autonomous, structured and goal-oriented mindset with a solution oriented balance of short term mitigation and long term solution
- Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport
- Performing well under pressure and decisiveness
- Excellent communication skills in German and English
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
Application Submission Deadline: 07.10.2026