Product Quality Engineer

ITech Consult AG; Zug; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

ITech Consult is seeking a Product Quality Engineer for the IVD product manufacturing domain in Rotkreuz. You will plan and ensure testing aligns with GMP, ISO 13485, IVDR, and FDA 21 CFR 820, and drive test equipment qualification and validation activities.

The ideal candidate has a MSc/BE in Engineering or Natural Science with 3+ years' GMP experience, strong QA skills, and fluent German and English. Travel up to 10% is required.

Qualifikationen

• Degree in Engineering or Natural Science with GMP knowledge.
• Experience in IVD manufacturing and testing environments.
• Knowledge of QA and regulatory guidelines (ISO 13485, IVDR, FDA 21 CFR 820).

Aufgaben

• Transfer product specifications into test equipment requirements.
• Define and develop test equipment and acceptance criteria.
• Create test plans and implement testing at supplier and RDI.
• Determine sample sizes for IPC, product release, and incoming inspection.
• Train staff on product quality inspection procedures.
• Review test equipment qualifications and method validation.

Kenntnisse

GMP experience

IVD manufacturing

Test equipment qualification

Test method validation

Lean Six Sigma knowledge

German & English communication

Ausbildung

M.Sc or B.Sc in Engineering or Natural Science

Apprenticeship with high subject matter expertise

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.