Product Quality Engineer

Coopers Group; Rotkreuz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Coopers Group is seeking a qualified specialist to translate product specifications into robust test equipment and validation plans in a GMP/IVD setting. The role focuses on test equipment qualification, method validation, and ensuring compliance with ISO 13485, IVDR, and FDA guidelines.

You will work cross-functionally, manage test plans, and guide supplier and internal teams. Travel up to 10% is expected, with strong communication in German and English a must.

Qualifikationen

• MSc/BSc in Engineering or Natural Science or apprenticeship with high expertise.
• 3+ years in GMP regulated, production environment.
• Experience in IVD product manufacturing and testing.
• Knowledge of Process Management methodologies (Lean, Six Sigma, etc.).
• Experience in test equipment qualification and test method validation.
• Knowledge of in-vitro diagnostic regulations (ISO 13485, IVDR, FDA 21 CFR part 820).
• Ability to think strategically and systemically, open to changes.
• Self-motivated, autonomous, structured and goal-oriented with a solution focus.

Aufgaben

• Transfer product specifications into test equipment requirements (URS).
• Define and develop test equipment.
• Define acceptance criteria for test equipment.
• Accountable for creation of test plan.
• Implement test planning at supplier and RDI.
• Define sample size for IPC, product release testing and incoming goods inspection.
• Conduct internal and supplier trainings on product quality inspection.
• Accountable for test equipment qualification and test method validation including correlation to RDI equipment.
• Review technical Q&V documentation at suppliers for qualification/validation.
• Review first article inspection (FAI) and verify tolerance data.
• Assess changes to test equipment and planning from a technical standpoint.

Kenntnisse

Strategic thinking

Systemic thinking

Communication skills

Autonomous working

Pressure handling

Change management

Team collaboration

Leadership potential

Ausbildung

MSc/BSc in Engineering or Natural Science

Apprenticeship with high subject matter expertise

Jobbeschreibung

Tasks & Responsibilities:

• 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) incl. verification 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 qualification 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%