Product Quality Engineer

• Engineering - Quality Management
• Zug
• Contracting
• Vollzeit
• Medizintechnik, Quality

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
• 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
• Travel required up to 10%