Quality Engineer - New product development

ppbQuality Engineer - New product development /b /p /p ppbApply for Job /b /p /p Enter your email to apply pbDate: /bJul 23, 2026 /p p bLocation: /b Altdorf, CH, 6460 Karlsbad-Ittersbach, DE, 76307 Pregnana Milanese, IT, 20010 /p p bCompany: /b Datwyler /p pIn 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 pbQuality Engineer - New product development /b /p pAs a bQuality Engineer - New product development /b, 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 pbKey Responsibilities /b /p liAct as the Quality representative within cross-functional NPI projects. /li liDrive quality excellence throughout product and process development. /li liDefine and support validation strategies (IQ/OQ/PQ/PPQ). /li liLead and facilitate risk assessments, including FMEA and contamination control activities. /li liEnsure GMP compliance and inspection readiness. /li liIntegrate NPI activities into quality systems, including change control, CAPA, and deviations. /li liSupport engineering runs, validation batches, technology transfers, scale-up activities, and commercial launches. /li pbWhat We’re Looking For /b /p liMaster's degree in Engineering, Chemistry, Life Sciences, or a related field. /li li5-8 years of experience in medical devices, pharmaceuticals, or another highly regulated industry. /li liStrong knowledge of GMP requirements, validation, and risk management. /li liExperience with IQ/OQ/PQ/PPQ, FMEA, and quality systems. /li liFamiliarity with standards such as EU GMP, Annex 1, FDA, ISO 13485, and ISO 14971. /li liStrong stakeholder management and collaboration skills. /li liFluent English communication skills. /li pbWhat We Offer /b /p libAttractive compensation package /b that rewards your expertise and impact. /li libFlexible working arrangements /b with hybrid options to support a healthy work-life balance. /li libContinuous learning and development opportunities /b to help you grow your skills and advance your career. /li liThe chance to bwork with cutting-edge technologies /b across bexciting, fast-evolving industries /b. /li liA bcollaborative, high-performing team environment /b where your ideas and contributions truly make a difference. /li pbReady to join us? Click “Apply now” /b /p 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 p#LI-SS1 /p pbBe yourself at Datwyler /b /p 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 ppbApply for Job /b /p /p Enter your email to apply