Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-standing client, Roche Diagnostics International AG in Rotkreuz, we are looking for a

Product Quality Engineer

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 speci?cations. 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 speci?cation into test equipment requirements (URS)
• De?ne and develop test equipment
• De?ne acceptance criteria for test equipment
• Accountable for creation of test plan
• Implementation of test planning at supplier and RDI
• De?ne 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 quali?cation, test method validation, including correlation studies to RDI test equipment
• Technical Q&V documentation review at supplier regarding test equipment quali?cation, test method validation
• Responsible for review of ?rst article inspection (FAI) incl. veri?cation 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 quali?cation 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
• Excellent communication skills in German and English
• Travel required up to 10% 

What we offer:

• Long-term assignment
• No travel required
• Opportunity to contribute to one of the world’s leading diagnostic companies
• Modern campus with green spaces and areas for interaction
• Central location with motorway access and nearby train station
• Varied and interesting range of tasks
• Further training opportunities through temptraining
• Collaboration within a dynamic and motivated team of 19
• Competitive compensation

You are welcome to send your complete application documents to Ms Nadine Rutz. 

Chemistry  Pharma Pharmacy Diagnostics Zug Lucerne Full-time Qualitätsingenieur Invitrodiagnostik