NPI Quality Engineer - MedTech Product Launch

Datwyler; Schweiz; Hybrid; EUR 128.893 - 193.339; Vollzeit

Benefits dieser Stelle

Attractive compensation package

Hybrid work arrangements

Continuous learning and development

Cutting-edge technologies exposure

Collaborative, high-performing team

Zusammenfassung

Datwyler is seeking a Quality Engineer for New Product Development to drive quality across new healthcare products and manufacturing processes. You will collaborate with Project Managers, Engineers, Operations and Validation teams to embed quality, compliance and patient safety from concept through launch.

The role requires a Master’s degree and 5–8 years of experience in regulated industries, with strong knowledge of GMP, validation and risk management. Hybrid work options are available.

Qualifikationen

• Master's degree in Engineering, Chemistry, Life Sciences, or a related field.
• 5-8 years of experience in medical devices, pharmaceuticals, or another highly regulated industry.
• Strong knowledge of GMP requirements, validation, and risk management.
• Experience with IQ/OQ/PQ/PPQ, FMEA, and quality systems.
• Familiarity with EU GMP, Annex 1, FDA, ISO 13485, and ISO 14971.
• Strong stakeholder management and collaboration skills.

Aufgaben

• Act as the Quality representative within cross-functional NPI projects.
• Drive quality excellence throughout product and process development.
• Define and support validation strategies (IQ/OQ/PQ/PPQ).
• Lead and facilitate risk assessments, including FMEA and contamination control activities.
• Ensure GMP compliance and inspection readiness.
• Integrate NPI activities into quality systems, including change control, CAPA, and deviations.
• Support engineering runs, validation batches, technology transfers, scale-up activities, and commercial launches.

Kenntnisse

Stakeholder management

Cross-functional collaboration

Ausbildung

Master's degree in Engineering, Chemistry, Life Sciences, or related field

Tools

IQ/OQ/PQ/PPQ

FMEA

GMP

ISO 13485

ISO 14971

Jobbeschreibung

Datwyler is seeking a Quality Engineer for New Product Development to drive quality across new healthcare products and manufacturing processes. You will collaborate with Project Managers, Engineers, Operations and Validation teams to embed quality, compliance and patient safety from concept through launch.

The role requires a Master’s degree and 5–8 years of experience in regulated industries, with strong knowledge of GMP, validation and risk management. Hybrid work options are available.