Product Quality Engineer

Product Quality Engineer: IVD product manufacturing / GMP / Q&V documentation / ISO 13485, IVDR, FDA 21 CFR part 820 / ISO 13485, IVDR, FDA 21 CFR part 820 / English / Deutsch Background: 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 or 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:

Must Haves:

Reference Nr.: 925281 Rolle: Product Quality Engineer Industry: Pharma Location: Rotkreuz

Start: ( Duration: 12 + Months Deadline:

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com. Contact us for more information about our company, our positions, or our attractive payroll-only program: .

Pensum

80 - 100%

• 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
• or 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
• Performing well under pressure and decisiveness
• Excellent communication skills in German and English
• Travel required up to 10%