{"id":2838171,"url":"https://alion.io/job/stryker-staff-npi-quality-engineer-2","title":"(Staff) NPI Quality Engineer","company":{"id":2579,"name":"Stryker","domain":"stryker.com","url":"https://alion.io/company/stryker","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":122,"ghost_share":0,"stale_share":0.639,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","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":{"min_usd":34000,"max_usd":78000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1625},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Sterilization Validation","optional":false},{"name":"GMP","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-10-19T07:50:49Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-22T16:54:36Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Work Flexibility: OnsitePOSITION SUMMARY\nSupports and executes design for manufacture and assembly through technical leadership in quality assurance, design control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. Support the development and characterization of processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQA’s, CTQ’s and MSA’s to enable process risk identification, process characterization, capability and robust process control. Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Provide Quality engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.\nPOSITION REQUIREMENTS\nWill reside within the NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following:\nGeneral\nFoster and lead collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities. Drive and lead effective communication with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.\nCommunicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.\nMentor other groups and functions on areas of expertise with particular attention to design and process transfer.\nRisk Management\nProficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).\nSupport the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA.\nEnsure all Risk Management outputs comply with ISO14971.\nSupport Design team to complete CQA/CTQ identification and inputs to dFMEA.\nInspection\nDevelop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.\nLead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.\nLead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.\nDevelop Measurement System Analysis (MSA) strategy and approve executed MSAs.\nValidation\nSupport the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.\nInfluence processes towards validation versus manual verification, where possible.\nSupport Sterilisation validation activity, as required.\nProcess Excellence\nApply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.\nProvide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.\nSupport Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.\nSupport ‘process bench marking’ by providing quality experience as a process input.\nWill promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.\nPurchasing Controls\nSupport the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations.\nProvide Quality input to influence the proper selection of suppliers.\nSupport implementation of supplier certification.\nSupport Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.\nDesign Transfer\nRepresent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including Right First Time (RFT), manufacturing loss, inspection costs per unit and product escapes, in conjunction with other targets per the DTAP.\nProvide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.\nRepresent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.\nSupport device design into production specifications.\nLead the efficient and timely transfer of lessons learnt knowledge to Quality engineering support, and regional peers.\nProvide expert quality process support post launch per DTAP agreement.\nSupport the control of product, through appropriate system containment to guard against product escape during pre-released builds.\nQUALIFICATION KNOWLEDGE SKILLS\nBachelor of Science, Engineering or related subject with 4 years’ experience in a quality or technical discipline or\nMaster of Science, Engineering or related subject with 2 years of experience in a quality or technical discipline or\nNote: Local qualifications may differ and will take precedence over the above criteria\nPrevious experience in a regulated environment within a manufacturing environment required. 2 years’ experience in new product/process is a distinct advantage.\nCQE or equivalent course work / experience desirable\nFamiliarity with advanced product quality planning framework and techniques used to develop products, a distinct advantage.\nProficient in understanding of Med Device manufacturing processes desirable.\nFamiliarity with ISO 13485, QSR, GDP, GMP desirable.\nLean Six Sigma training a distinct advantage.\nHighly proficient in all aspects of Validation. Computer System validation a distinct advantage.\nAnalytical & problem-solving skills, process improvement orientation, and the ability to handle multiple tasks.\nCompetency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance.\nMust be able to generate, follow and explain detailed operating procedures\nExperience in executing complex problem-solving and process improvements techniques related to design/process/technical issues using lean six sigma tools like DMAIC.\nExcellent analytical skills, ability to plan, organize and implement concurrent tasks.\nExcellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.\nWorking knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA’s.\nManages change well and adopts a continuous improvement mindset\nExcellent English (both oral and written)\nAbility to be the voice of quality when dealing cross functionally\nTravel Percentage: 10%","description_format":"text","description_chars":8054,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Neurotech & Neuromodulation","Hospital Equipment & Furniture"],"lifecycle":[{"event":"open","at":"2026-10-19T07:50:49Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":33,"reasons":["conf:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/stryker-staff-npi-quality-engineer-2","json_url":"https://alion.io/job/stryker-staff-npi-quality-engineer-2.json","meta":{"generated_at":"2026-10-22T18:07:57Z","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":533,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":2579},"rest":"https://alion.io/mcp/rest/get_company?id=2579"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fstryker-staff-npi-quality-engineer-2"},{"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%2Fstryker-staff-npi-quality-engineer-2"},{"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%2Fstryker-staff-npi-quality-engineer-2"},{"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/stryker-staff-npi-quality-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstryker-staff-npi-quality-engineer-2"}]}