Quality Engineer - Medical Device NPI (Hybrid)

Datwyler Group; Valparaíso; Híbrido; CLP 85.227.273 - 123.106.061; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work options

Continuous learning opportunities

Competitive compensation

Descripción de la vacante

Datwyler is seeking a Quality Engineer for New Product Development to ensure quality, compliance, and patient safety throughout the product development and launch process. The role collaborates with Project Managers, Engineers, Operations, and Validation teams to embed quality from concept to commercialization.

Ideal candidates have a Master’s degree in a relevant field and 5–8 years in regulated industries, with strong GMP, validation, and risk-management expertise, including IQ/OQ/PQ and FMEA.

Formación

• 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.
• Fluent English communication skills.

Responsabilidades

• 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.

Conocimientos

Quality engineering

GMP knowledge

IQ/OQ/PQ

FMEA

English proficiency

Educación

Master's degree in Engineering, Chemistry, Life Sciences

Descripción del empleo

Datwyler is seeking a Quality Engineer for New Product Development to ensure quality, compliance, and patient safety throughout the product development and launch process. The role collaborates with Project Managers, Engineers, Operations, and Validation teams to embed quality from concept to commercialization.

Ideal candidates have a Master’s degree in a relevant field and 5–8 years in regulated industries, with strong GMP, validation, and risk-management expertise, including IQ/OQ/PQ and FMEA.