{"id":3894579,"url":"https://alion.io/job/stryker-quality-system-specialist","title":"Quality System Specialist","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":"A","score":85,"open_postings":126,"ghost_share":0.008,"stale_share":0.579,"repost_share":0.016,"time_to_fill_p50_days":34,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Redmond, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":76500,"max":117100,"currency":"USD","period":"year","gross":null,"usd_annual":117100},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-06T22:41:54Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-08T16:49:58Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Work Flexibility: HybridAs theQuality System Specialist you will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification. This role isHybrid in Redmond, Washington.\nWhat you will do\nSupport QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).\nManage documents and document changes throughout QMS document lifecycle within electronic documentation system\nFacilitate engineering documentation management within electronic documentation system including DMR, DHF and technical standards.\nPerform change control/configuration management checks to engineering documentation to ensure compliance with local procedures\nAdminister and maintain the electronic document management system, ensuring user access, permissions, and training records remain current.\nPerform document control checks to ensure documents and document changes comply with local procedures.\nProvide guidance to process owners, document creators, document reviewers and document approvers on the overall process and electronic management system.\nIdentify improvements and inputs into the quality planning process\nExecute development and/or modifications of Stryker’s QMS\nSupport Management Review and Quality Planning Review and related forums.\nSupport GMP and GDP within Quality organization.\nSupport QMS training development and delivery.\nSupport implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.\nSupport notified body communication.\nEnsure QMS reflects actual activities, business needs and supports NPD requirement.\nCoordinate internal and external audits, including securing conference rooms, communicating with SPOs/SMEs, and coordinating front room/back room logistics.\nSupport internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.\nWhat you need\nBachelor’s Degree in a science, engineering or related discipline, or equivalent experience\n0-2 years experience in manufacturing environment or equivalent.\nPreferred\nMinimum of 2 years experience in area of quality systems, engineering, or equivalent experience preferred.\nExperience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)\nDemonstrated knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply.\nKnowledge and understanding of U.S. and International medical device regulations.\nKnowledge of supporting Quality Systems (audits, management review, quality planning, etc.)\nStrong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.\nStrong written and oral communication and negotiation skills.\nStrong critical thinking skills.\nDeveloped problem-solving skills.\nStrong analytical skills.\nDemonstrated ability to successfully manage and complete projects in a matrix organization.\nDemonstrated ability to work independently.\nExperience working in a compliance-risk situation.\nComputer literacy, including Microsoft Word, Excel and PowerPoint.\nSome travel may be required.\nUnited States of America Pay Ranges:\nUS15: $76,500 - $117,100 USD Annual\nView the U.S. work location and transparency guide to find the pay range for your location.\nTravel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.","description_format":"text","description_chars":4807,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Neurotech & Neuromodulation","Hospital Equipment & Furniture"],"lifecycle":[{"event":"open","at":"2026-11-06T22:41:54Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 73 · green card filings: 27","filings_12m":73,"filings_prev_12m":92,"green_card_filings_12m":27,"median_offered_wage_usd":133850,"route":null,"cap_exempt":false,"checked_at":"2026-11-08T10:45:15+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":34,"reasons":["conf:4","stale_co","velocity","win:early","comp:junior,brand"],"computed_at":"2026-11-08T05:47:12Z"},"pay":{"stated_usd_annual":117100,"is_top_pay":true},"html_url":"https://alion.io/job/stryker-quality-system-specialist","json_url":"https://alion.io/job/stryker-quality-system-specialist.json","meta":{"generated_at":"2026-11-08T21:46:34Z","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":45449,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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-quality-system-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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-quality-system-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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-quality-system-specialist"},{"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-quality-system-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstryker-quality-system-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3894579}},{"tool":"search_jobs","arguments":{"company":"stryker.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3894579},"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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