{"id":3096898,"url":"https://alion.io/job/koch-industries-quality-engineer-10","title":"Quality Engineer","company":{"id":13911,"name":"Koch Industries","domain":"kochinc.com","url":"https://alion.io/company/kochinc","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Avature","truth_index":{"grade":"A","score":100,"open_postings":19,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Suzhou, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-22T16:21:41Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-29T20:40:35Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Our Team\nYou 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.\nWhat You Will Do\nPerform technical investigations on returned market devices to determine whether the reported complaint can be confirmed.\nPlan and execute investigation activities according to approved protocols, work instructions, and QMS requirements.\nConduct mechanical inspections, functional testing, disassembly, and component-level evaluation of returned devices.\nDefine and document investigation methods, test scenarios, and acceptance criteria together with relevant technical stakeholders.\nPerform root cause analysis and determine whether the identified cause is related to manufacturing, components, raw materials, handling, or use.\nDocument investigation results in clear, complete, traceable, and auditable investigation reports.\nAssign relevant investigation findings and conclusion codes in accordance with the applicable complaint handling process.\nSupport the Customer Complaints Team Lead in India with technical input, evidence, and conclusions required to close complaints.\nEscalate potential product, process, safety, or risk-related findings through the agreed escalation path.\nSupport risk assessment activities by providing investigation evidence and technical input to the risk management process.\nInitiate and support corrections and CAPA/ SCAR activities together with manufacturing, suppliers, product maintenance, and quality teams.\nCoordinate device receipt, handling, traceability, storage, and archiving of returned devices at the Suzhou site.\nSupport trend monitoring of manufacturing-related complaint findings and propose product and process improvements.\nProvide technical support and guidance to production and quality colleagues related to complaint investigations.\nEnsure all deliverables are completed in line with applicable QMS procedures, good documentation practices, and regulatory expectations.\nSupport internal and external audits, inspections, and customer-related quality reviews as required.\nWho You Are (Basic Qualifications)\nPerform technical investigations on returned market devices to determine whether the reported complaint can be confirmed.\nPlan and execute investigation activities according to approved protocols, work instructions, and QMS requirements.\nConduct mechanical inspections, functional testing, disassembly, and component-level evaluation of returned devices.\nDefine and document investigation methods, test scenarios, and acceptance criteria together with relevant technical stakeholders.\nPerform root cause analysis and determine whether the identified cause is related to manufacturing, components, raw materials, handling, or use.\nDocument investigation results in clear, complete, traceable, and auditable investigation reports.\nAssign relevant investigation findings and conclusion codes in accordance with the applicable complaint handling process.\nSupport the Customer Complaints Team Lead in India with technical input, evidence, and conclusions required to close complaints.\nEscalate potential product, process, safety, or risk-related findings through the agreed escalation path.\nSupport risk assessment activities by providing investigation evidence and technical input to the risk management process.\nInitiate and support corrections and CAPA/ SCAR activities together with manufacturing, suppliers, product maintenance, and quality teams.\nCoordinate device receipt, handling, traceability, storage, and archiving of returned devices at the Suzhou site.\nSupport trend monitoring of manufacturing-related complaint findings and propose product and process improvements.\nProvide technical support and guidance to production and quality colleagues related to complaint investigations.\nEnsure all deliverables are completed in line with applicable QMS procedures, good documentation practices, and regulatory expectations.\nSupport internal and external audits, inspections, and customer-related quality reviews as required.\nWhat Will Put You Ahead\nExperience with medical device complaint handling, post-market activities, or vigilance-related processes.\nKnowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, or comparable regulated quality frameworks.\nExperience supporting CAPA/ SCAR, corrections, and continuous improvement initiatives.\nExperience collaborating with customers or global quality organizations on technical investigations.\nProven track record of technical investigations and root cause determination on mechanical medical devices, preferably pen injectors.\nAbility to translate technical findings into clear, compliant, and customer-ready conclusions.\nExperience linking investigation outcomes to manufacturing process improvements and risk management.\nExperience working in a matrix organization with local and global reporting relationships.\nAt 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.\n\nWho We Are\nPhillips 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.\nAt 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.\nAdditionally, 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.","description_format":"text","description_chars":6918,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Paper & Pulp Manufacturing","Chemical Manufacturing","Glass & Ceramics Manufacturing","Oil & Gas"],"lifecycle":[{"event":"open","at":"2026-10-22T16:21:41Z"}],"visa":[],"liveness":{"score":82,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.908,"p_room":0.9,"age_days":6,"expected_fill_days":15,"reasons":["conf:3","wave","velocity","win:mid","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/koch-industries-quality-engineer-10","json_url":"https://alion.io/job/koch-industries-quality-engineer-10.json","meta":{"generated_at":"2026-10-29T22:25:10Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":33153,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":13911},"rest":"https://alion.io/mcp/rest/get_company?id=13911"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkoch-industries-quality-engineer-10"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fkoch-industries-quality-engineer-10"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fkoch-industries-quality-engineer-10"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/koch-industries-quality-engineer-10\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkoch-industries-quality-engineer-10"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3096898}},{"tool":"search_jobs","arguments":{"company":"kochinc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3096898},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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