ppIn 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. /p pOur 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... /p h3Quality Engineer - New product development /h3 pAs 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. /p h3Key Responsibilities /h3 ulliAct as the Quality representative within cross-functional NPI projects. /liliDrive quality excellence throughout product and process development. /liliDefine and support validation strategies (IQ/OQ/PQ/PPQ). /liliLead and facilitate risk assessments, including FMEA and contamination control activities. /liliEnsure GMP compliance and inspection readiness. /liliIntegrate NPI activities into quality systems, including change control, CAPA, and deviations. /liliSupport engineering runs, validation batches, technology transfers, scale-up activities, and commercial launches. /li /ul h3What We're Looking For /h3 ulliMaster's degree in Engineering,



Chemistry, Life Sciences, or a related field. /lili5-8 years of experience in medical devices, pharmaceuticals, or another highly regulated industry. /liliStrong knowledge of GMP requirements, validation, and risk management. /liliExperience with IQ/OQ/PQ/PPQ, FMEA, and quality systems. /liliFamiliarity with standards such as EU GMP, Annex 1, FDA, ISO 13485, and ISO 14971. /liliStrong stakeholder management and collaboration skills. /liliFluent English communication skills. /li /ul h3What We Offer /h3 ulliAttractive compensation package that rewards your expertise and impact. /liliFlexible working arrangements with hybrid options to support a healthy work-life balance. /liliContinuous learning and development opportunities to help you grow your skills and advance your career. /liliThe chance to work with cutting-edge technologies across exciting, fast-evolving industries. /liliA collaborative, high-performing team environment where your ideas and contributions truly make a difference. /li /ul pDatwyler 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. /p h3Be yourself at Datwyler /h3 pWe 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. /p /p #J-18808-Ljbffr

📌 Quality Engineer - New product development (Pregnana Milanese)
🏢 Datwyler Group
📍 Pregnana Milanese