Product Quality Engineer

ITech Consult AG; Rotkreuz; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

ITech Consult AG is seeking a Product Quality Engineer for Rotkreuz to lead the testing strategy for external manufacturing in the diagnostic workflow. You will translate specifications into test equipment requirements and drive qualification and validation activities in collaboration with RDI and suppliers.

The role requires a MSc/BSc in engineering or an equivalent apprenticeship with deep subject matter expertise, 3+ years in GMP environments, and fluency in German and English.

Qualifikationen

• M.Sc. or B.Sc. in Engineering or apprenticeship with high subject matter expertise.
• 3+ years of relevant work experience in a GMP regulated, producing company.
• Experience in IVD product manufacturing and testing.
• Knowledge of Lean, Six Sigma, or other process management methods.
• Experience with test equipment qualification and test method validation.
• Knowledge of ISO 13485, IVDR, and FDA 21 CFR Part 820 regulations.
• Strong communication in German and English, with travel up to 10%.

Aufgaben

• Transfer product specifications into test equipment requirements (URS).
• Define and develop test equipment and acceptance criteria.
• Create and implement test plans at supplier and RDI.
• Define sample sizes for IPC, product release testing, and incoming goods inspection.
• Conduct internal and supplier trainings on product quality inspection.
• Review test equipment qualification, test method validation, and FAI documentation.

Kenntnisse

Strategic thinking

Process Management (Lean / Six Sigma)

Communication (German & English)

Ausbildung

M.Sc. in Engineering

B.Sc. in Engineering

Apprenticeship in engineering (subject matter expert)

Jobbeschreibung

Product Quality Engineer: IVD product manufacturing / GMP / Q&V documentation / ISO 13485, IVDR, FDA 21 CFR part 820 / ISO 13485, IVDR, FDA 21 CFR part 820 / English / Deutsch

Background

External Manufacturing is the competence center 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 you are responsible for the planning and state of the art measurement of the technical test speci?cations. This role assures that the products are tested compliant to the regulations, including statistical sampling plan and test procedures. The Product Quality Engineer provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.

The Perfect Candidate has a M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with a high degree of subject matter expertise and at least 3 years of relevant work experience in a GMP regulated, producing company.

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 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
• Travel required up to 10%

Reference Nr.: 925281
Rolle: Product Quality Engineer
Industry: Pharma
Location: Rotkreuz
Pensum: 80 - 100%
Start: 01.11.2026 (01.01.2027)
Duration: 12 + Months
Deadline: 07/09/2026

About us

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.