Product Quality Engineer (m/f/d)

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

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Product Quality Engineer for a temporary assignment of 12 months, with high probability of extension. External Manufacturing is the competence center at Roche for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement. As a Product Quality Engineer, the role holder is responsible for the planning and state-of-the-art measurement of the technical test specifications. This role assures that the products are tested compliant to the regulations, including statistical sampling plans and test procedures. The Product Quality Engineer provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.

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 an apprenticeship with a 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
• Knowledge of 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
• Willingness to travel up to 10%

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts