Product Quality Planner

Product Quality Planner

As a Product Quality Planner, 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 Planner provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.

Your Responsibilities:

• Transfer product specification into test equipment requirements (URS)
• Define and develop test equipment and acceptance criteria, test plans
• 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

Your background:

• M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines
• 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
• Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
• Experienced in test equipment qualification 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