Overview
Product Quality Planner/a Jobs in Rotkreuz, Kanton Zug, Switzerland at TN Switzerland
Position: Product Quality Planner (a)
Location: Rotkreuz
Roche Diagnostics in Rotkreuz (ZG), the world leader in in-vitro diagnostics, is looking for a motivated team player with experience in test equipment qualification and test method validation in a GMP-regulated manufacturing company.
Product Quality Planner (a)
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 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.
Transfer product specification into test equipment requirements (URS)
Define and develop test equipment
Define acceptance criteria for test equipment
Accountable for creation of test plan
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) including verification of the tolerance situation
Technical assessment of changes of test equipment and test planning
Minimum Qualifications:
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 qualification and test method validation
Excellent communication skills in German and English
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
Travel required up to 10% (global including USA and China)
Your application
Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), ()
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Title: Product Quality Planner/a
Company: TN Switzerland
Location: Rotkreuz, Kanton Zug, Switzerland
Category: Quality Assurance – QA/QC (Quality Engineering, Quality Control / Manager), Engineering (Quality Engineering)
