Quality Engineer - New product development

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

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 global 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 industry.
• Strong knowledge of GMP requirements, validation, and risk management.
• Experience with IQ/OQ/PQ/PPQ, FMEA, and quality systems.
• Familiarity with standards such as EU GMP, Annex 1, FDA, ISO 13485, and ISO 14971.
• Strong stakeholder management and collaboration skills.
• Fluent English communication skills.

What We Offer

• Attractive compensation package that rewards your expertise and impact.
• Flexible working arrangements with hybrid options to support a healthy work-life balance.
• Continuous learning and development opportunities to help you grow your skills and advance your career.
• The chance to work with cutting-edge technologies across exciting, fast-evolving industries.
• A collaborative, high-performing team environment where your ideas and contributions truly make a difference.

Datwyler is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

www.datwyler.com