Product Quality Engineer

Product Quality Engineer #

(m/f/d)

Freelance/temporary employment for a project

Zug

Start date: asap

Reference number: 896308/1

Transfer product speci?cation into test equipment requirements (URS)
Define and develop test equipment and define 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 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

University degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
Proven relevant work experience in a GMP regulated, producing company
Experience in IVD product manufacturing and testing and proven relevant work experience in a GMP regulated, producing company
Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
Experienced in test equipment qualification 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

Posted 2 days ago