Quality Engineer

Job description

Location(s) Suzhou, Jiangsu Company Phillips Medisize Career Field Quality Job Number 196469 Apply now Share Email Facebook X LinkedIn Our Team You will be part of the Global Quality & Regulatory organization, within the Customer Complaints team, working closely with quality, manufacturing, product maintenance, and regulatory teams across China, India, and Europe. The team is responsible for establishing and driving a robust customer complaint handling capability that supports product quality, patient safety, regulatory compliance, and continuous improvement for global medical device customers. Based in Suzhou and close to manufacturing, you will be the technical investigation link between returned market devices and the global complaint handling process. What You Will Do • Perform technical investigations on returned market devices to determine whether the reported complaint can be confirmed. • Plan and execute investigation activities according to approved protocols, work instructions, and QMS requirements. • Conduct mechanical inspections, functional testing, disassembly, and component-level evaluation of returned devices. • Define and document investigation methods, test scenarios, and acceptance criteria together with relevant technical stakeholders. • Perform root cause analysis and determine whether the identified cause is related to manufacturing, components, raw materials, handling, or use. • Document investigation results in clear, complete, traceable, and auditable investigation reports. • Assign relevant investigation findings and conclusion codes in accordance with the applicable complaint handling process. • Support the Customer Complaints Team Lead in India with technical input, evidence, and conclusions required to close complaints. • Escalate potential product, process, safety, or risk-related findings through the agreed escalation path. • Support risk assessment activities by providing investigation evidence and technical input to the risk management process. • Initiate and support corrections and CAPA/ SCAR activities together with manufacturing, suppliers, product maintenance, and quality teams. • Coordinate device receipt, handling, traceability, storage, and archiving of returned devices at the Suzhou site. • Support trend monitoring of manufacturing-related complaint findings and propose product and process improvements. • Provide technical support and guidance to production and quality colleagues related to complaint investigations. • Ensure all deliverables are completed in line with applicable QMS procedures, good documentation practices, and regulatory expectations. • Support internal and external audits, inspections, and customer-related quality reviews as required. Who You Are (Basic Qualifications) • Perform technical investigations on returned market devices to determine whether the reported complaint can be confirmed. • Plan and execute investigation activities according to approved protocols, work instructions, and QMS requirements. • Conduct mechanical inspections, functional testing, disassembly, and component-level evaluation of returned devices. • Define and document investigation methods, test scenarios, and acceptance criteria together with relevant technical stakeholders. • Perform root cause analysis and determine whether the identified cause is related to manufacturing, components, raw materials, handling, or use. • Document investigation results in clear, complete, traceable, and auditable investigation reports. • Assign relevant investigation findings and conclusion codes in accordance with the applicable complaint handling process. • Support the Customer Complaints Team Lead in India with technical input, evidence, and conclusions required to close complaints. • Escalate potential product, process, safety, or risk-related findings through the agreed escalation path. • Support risk assessment activities by providing investigation evidence and technical input to the risk management process. • Initiate and support corrections and CAPA/ SCAR activities together with manufacturing, suppliers, product maintenance, and quality teams. • Coordinate device receipt, handling, traceability, storage, and archiving of returned devices at the Suzhou site. • Support trend monitoring of manufacturing-related complaint findings and propose product and process improvements. • Provide technical support and guidance to production and quality colleagues related to complaint investigations. • Ensure all deliverables are completed in line with applicable QMS procedures, good documentation practices, and regulatory expectations. • Support internal and external audits, inspections, and customer-related quality reviews as required. What Will Put You Ahead • Experience with medical device complaint handling, post-market activities, or vigilance-related processes. • Knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, or comparable regulated quality frameworks. • Experience supporting CAPA/ SCAR, corrections, and continuous improvement initiatives. • Experience collaborating with customers or global quality organizations on technical investigations. • Proven track record of technical investigations and root cause determination on mechanical medical devices, preferably pen injectors. • Ability to translate technical findings into clear, compliant, and customer-ready conclusions. • Experience linking investigation outcomes to manufacturing process improvements and risk management. • Experience working in a matrix organization with local and global reporting relationships. At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. Who We Are Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference. At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results. Apply now Share Email Facebook <a id="shareButton--twitter" class="shareButton shareButton--twitter tpt_socialShareIcon tpt_socialSharePopupTrigger visibility--hidden" aria-label="Share Quality Engineer on X" role="link" tabindex="0" target="_blank" href="http://twitter.com/intent/tweet?url=https%3A%2F%2Fkoch.avature.net%2Fen_US%2Fcareers%2FJobDetail%2FQuality-Engineer%2F196469&text=Quality+Eng