Quality Engineer (Valparaíso)

Quality Engineer (Valparaíso)

12 ago
|
Datwyler Group
|
Valparaíso

12 ago

Datwyler Group

Valparaíso

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive general markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Quality Engineer - New product development

As a Quality Engineer - New product development, you will play a key role in bringing new healthcare products and manufacturing processes to life. Working closely with Project Managers, Engineers, Operations, and Validation teams,



you'll ensure quality, compliance, and patient safety are embedded throughout the entire product development and launch process.

Key Responsibilities
- 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.

What We're Looking For
- 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 i

📌 Quality Engineer (Valparaíso)
🏢 Datwyler Group
📍 Valparaíso

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