\\n \\n Tempor\\xc3\\xa4rJobregion: Rotkreuz, SchweizStellenprozente: 100 %Elektro & MechanikProduct Quality Planner (m/f/d)BeschreibungFor our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Product Quality Planner for one year with option for extension.Global 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 Planner, you are responsible for the planning and state of the art measurement of the technical test speci%uFB01cations. This role assures that the products are tested compliant to the regulations, including statistical sampling plan and test procedures. The Product Quality Planner provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.Tasks

• Transfer product speci%uFB01cation into test equipment requirements (URS)
• De%uFB01ne and develop test equipment
• De%uFB01ne acceptance criteria for test equipment
• Accountable for creation of test plan
• Implementation of test planning at supplier and RDI
• De%uFB01ne 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%uFB01cation, test method validation, including correlation studies to RDI test equipment
• Technical Q&V documentation review at supplier regarding test equipment quali%uFB01cation, test method validation
• Responsible for review of %uFB01rst article inspection (FAI) incl. veri%uFB01cation 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, and with in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.
• Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
• Experienced in test equipment quali%uFB01cation and test method validation
• 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%

Are you interested? Do not hesitate and submit your complete application documents online today.We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!Wir wertsch\\xc3\\xa4tzen Vielfalt und begr\\xc3\\xbcssen daher alle Bewerbungen - unabh\\xc3\\xa4ngig von Geschlecht, sozialer Herkunft, Religion, Alter und Identit\\xc3\\xa4t. Zur leichteren Lesbarkeit und besseren Verst\\xc3\\xa4ndlichkeit verwenden wir nur eine Gender-Form. Selbstverst\\xc3\\xa4ndlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.\\n \\n \\n \\n \\n \\n

\\n\\n \\n Work Selection\\n \\n\\n

\\n