IVD Product Quality Engineer - Test Equipment & QA Lead

Work Selection AG; Rotkreuz; Vor Ort; CHF 90.000 - 115.000; Vollzeit

Benefits dieser Stelle

On-site campus facilities

Staff restaurants

Parking spaces

Professional development support

Fleet discounts

Zusammenfassung

Work Selection AG, as a first-tier supplier to Roche Diagnostics in Rotkreuz, seeks a motivated Product Quality Engineer for a 12-month assignment with a strong extension potential. You will translate product specs into test requirements and ensure GMP-compliant testing across suppliers.

Responsibilities include defining test plans, qualifying test equipment, performing method validations, training colleagues, and supporting supplier audits in a GMP/IVD setting, with fluency in German and

Qualifikationen

• MSc or BSc in Engineering, Natural Science, or related field
• 3+ years of GMP-regulated production experience
• Experience in IVD product manufacturing and testing
• Knowledge of ISO 13485, IVDR, FDA 21 CFR Part 820
• Strategic and systemic thinking, proactive mindset
• Excellent communication in German and English
• Willingness to travel up to 10%

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
• 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
• 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

Jobbeschreibung

Work Selection AG, as a first-tier supplier to Roche Diagnostics in Rotkreuz, seeks a motivated Product Quality Engineer for a 12-month assignment with a strong extension potential. You will translate product specs into test requirements and ensure GMP-compliant testing across suppliers.

Responsibilities include defining test plans, qualifying test equipment, performing method validations, training colleagues, and supporting supplier audits in a GMP/IVD setting, with fluency in German and