{"id":3022257,"url":"https://alion.io/job/stryker-senior-quality-systems-specialist","title":"Senior Quality Systems 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":"B","score":82,"open_postings":143,"ghost_share":0,"stale_share":0.72,"repost_share":0.021,"time_to_fill_p50_days":32,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","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":83400,"max":139000,"currency":"USD","period":"year","gross":null,"usd_annual":139000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-21T18:08:07Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-28T02:46:07Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Work Flexibility: HybridAs a Senior Quality Systems Specialist, you will play a critical role in ensuring the effectiveness of Stryker's quality management system by driving compliance, leading problem-solving efforts, and partnering with cross-functional teams to resolve quality issues. This position offers the opportunity to influence quality excellence, continuous improvement, and regulatory compliance across the organization. This role isHybrid in Redmond, Washington.\n What You Will Do\nOwn and oversee the Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes to ensure compliance, effectiveness, and efficiency in addressing quality issues.\nReview and approve NCs and CAPAs for completeness, accuracy, effectiveness, and timeliness.\nPartner with cross-functional teams to facilitate investigations, root cause analysis, and corrective action implementation.\nServe as the site subject matter expert and super user for the eCAPA system, ensuring records are maintained with appropriate supporting evidence..\nCoach and mentor teams on problem-solving methodologies, including 5 Whys, Fishbone Diagrams, Process Mapping, Human Error Reduction, and 4-D methodologies.\nLead accountability meetings, CAPA review boards, and root cause analysis workshops to drive quality improvements.\nMonitor and report NC/CAPA key performance indicators (KPIs), providing updates for quality and business review forums.\nDevelop, maintain, and deliver training programs related to CAPA processes and quality systems.\nIdentify and implement continuous improvement initiatives to optimize quality systems and business processes.\nParticipate in cross-site and corporate quality system improvement projects.\nSupport internal, corporate, customer, and third-party audits, including preparation, participation, and follow-up activities.\nWhat You Need\nBachelor’s degree in Science, Engineering, or a related discipline.\nMinimum 3+ years of experience in a manufacturing environment or equivalent.\nStrong communication, project management, and influencing skills.\nDemonstrated ability to manage multiple priorities in a fast-paced, matrixed environment.\nStrong analytical, critical thinking, and problem-solving capabilities.\nAbility to work independently and drive issues to resolution.\nProficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.\nPreferred\n2+ years of experience in CAPA, Quality Systems, Quality Engineering, or a related field.\nExperience interacting with regulatory agencies such as FDA, TUV, and other international regulatory bodies.\nKnowledge of U.S., European, and international medical device regulations and standards.\nStrong understanding of quality system processes, including audits, management review, and quality planning.\nExperience working in compliance-risk environments.\nDemonstrated success leading projects and driving results across cross-functional teams.\nExcellent written, verbal, and negotiation skills.\nAbility to facilitate teams through complex investigations and root cause analyses.\nExperience supporting multi-site or global quality initiatives.\nWillingness to travel as needed.\nUnited States of America Pay Ranges:\nUS15: $83,400 - $139,000 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":4437,"description_truncated":false,"requirements":{"experience_years_min":3,"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":"2026-10-21T18:08:07Z"}],"visa":[{"country":"US","licensed_sponsor":true,"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":"2026-10-15T11:24:14+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":57,"band":"ok","label":"Likely open","p_open":0.9,"p_active":0.632,"p_room":1,"age_days":5,"expected_fill_days":32,"reasons":["conf:72","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":139000,"is_top_pay":false},"html_url":"https://alion.io/job/stryker-senior-quality-systems-specialist","json_url":"https://alion.io/job/stryker-senior-quality-systems-specialist.json","meta":{"generated_at":"2026-10-28T03:14:02Z","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":4348,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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-senior-quality-systems-specialist"},{"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-senior-quality-systems-specialist"},{"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-senior-quality-systems-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-senior-quality-systems-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstryker-senior-quality-systems-specialist"}]}