About this role
<p>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.</p> <p>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...</p> <p style="margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:18.0pt">Position Summary</span></strong></p> <p><span style="font-size:10.5pt;font-family:'Segoe UI', sans-serif">The Quality Engineer at Datwyler is responsible for ensuring that products, processes, and quality systems comply with internal standards, customer requirements, and applicable regulatory requirements. This role supports manufacturing and new product introduction through risk management, process validation, continuous improvement, and root cause analysis, contributing to Datwyler’s commitment to patient safety and product excellence.</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:18.0pt">Essential Functions</span></strong></p> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Quality Systems & Compliance</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Ensure compliance with <strong>ISO 13485</strong>, <strong>FDA 21 CFR 820</strong>, <strong>EU MDR</strong>, and other applicable regulatory and customer requirements.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Support internal, external, customer, and regulatory audits; prepare documentation and lead follow‑up activities.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Maintain and improve quality procedures, work instructions, and records.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Manufacturing & Process Support</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Oversight <strong>process validations</strong> (IQ, OQ, PQ) and maintain validation documentation.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Participate in <strong>PFMEA</strong>, <strong>Control Plans</strong>, and risk management activities.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Support containment, investigation, and resolution of nonconformities.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Continuous Improvement</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Oversight and support <strong>root cause investigations</strong> using tools such as 8D, Fishbone, and 5‑Why.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Implement <strong>corrective and preventive actions (CAPA)</strong> and verify effectiveness.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Drive continuous improvement initiatives using Lean and Six Sigma methodologies.</span><span style="font-size:10.5pt"> </span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">New Product Introduction (NPI)</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Support quality planning and risk assessments for new products and transfers.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Review customer specifications, drawings, and validation requirements.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Ensure quality deliverables are completed on time for project milestones.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Supplier & Customer Quality</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Support supplier qualification, audits, and performance monitoring.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Investigate customer complaints and ensure timely, compliant responses.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Collaborate with customers to resolve quality issues and improve satisfaction.</span></li> </ul> <p style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:18.0pt">Qualifications</span></strong></p> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Education</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Bachelor’s degree in <strong>Engineering</strong>, <strong>Quality</strong>, <strong>Science</strong>, or a related discipline.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Experience</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">2–5+ years of quality engineering experience in a <strong>regulated manufacturing environment</strong>, preferably <strong>medical device, pharmaceutical, or healthcare packaging</strong>.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Experience with molding or precision manufacturing processes preferred.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><strong><span style="font-size:13.5pt">Technical Skills</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Strong knowledge of: </span></li> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="circle"> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">ISO 13485</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">FDA 21 CFR 820</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Risk management (ISO 14971)</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Process validation</span></li> </ul> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Experience with statistical tools and SPC.</span></li> <li style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"><span style="font-size:10.5pt">Proficiency in MS Office; experience with eQMS systems is a plus.</span></li> </ul> <p style="line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Segoe UI', sans-serif"> </p><p> </p> <p><b>Be yourself at Datwyler</b></p> <p>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.</p> <p><a href="http://www.datwyler.com">www.datwyler.com</a></p>