Product Quality Engineer (m/f/d)

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

• 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

• Dynamic and innovative market environment
• A very renowned company

Ihr Kontakt

Referenznummer
896308/1

Kontakt aufnehmen
Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch

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