CAIRN.

Product Quality Engineer

Coopers Group AG

  • Engineering - Quality Management
  • Zug
  • Contracting
  • Vollzeit
  • Medizintechnik, Quality

Tasks & Responsibilities

  • Transfer product speci-cation into test equipment requirements (URS)
  • De-ne and develop test equipment
  • De-ne 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 quali-cation, test method validation, including correlation studies to RDI test equipment
  • Technical Q&V documentation review at supplier regarding test equipment quali-cation, test method validation
  • Responsible for review of -rst article inspection (FAI) incl. veri-cation of the tolerance situation
  • Technical assessment of changes of test equipment and test planning

Must Haves

  • 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
  • Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
  • Experienced in test equipment quali-cation and test method validation
  • In-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820
  • 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
  • Travel required up to 10% 

Offres similaires

Données OFS 2024 —

6'577 CHF / mois

Fourchette : 5'642 – 7'765 CHF (P25–P75), brut avant charges.

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