Job Title:
Product Quality Planner (m/f/d)
Location:
Rotkreuz, Switzerland
About the Role:
We are seeking a highly skilled Product Quality Planner to join our team at Roche Diagnostics International AG in Rotkreuz. As a Product Quality Planner, you will be responsible for planning and measuring technical test specifications to ensure compliance with regulations.
Key Responsibilities:
* Transfer product specification into test equipment requirements.
* Define and develop test equipment.
* Define acceptance criteria for test equipment.
* Accountable for creation of test plans.
* Implementation of test planning at supplier and RDI.
* Define sample size for in-process control, 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 incl. verification of the tolerance situation.
* Technical assessment of changes of test equipment and test planning.
Requirements:
* M.Sc- or B.Sc. degree in Engineering, Natural Science, or related disciplines.
* At least 3 years of relevant work experience in a GMP regulated company.
* Experience in IVD product manufacturing and testing, and with in-vitro diagnostic related regulations.
* Knowledge of Process Management methodologies (Lean, Six Sigma).
* Experienced in test equipment qualification and test method validation.
* Excellent communication skills in German and English.
What We Offer:
A competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.