{"id":1726954,"url":"https://alion.io/job/stryker-senior-quality-systems-specialist-integration","title":"Senior Quality Systems Specialist - Integration","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":"Operations","role_family":"Operations","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":["Belfast, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":35000,"max":58400,"currency":"GBP","period":"year","gross":null,"usd_annual":77284},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-02T22:25:19Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-24T05:33:23Z","board_verified":false,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"Work Flexibility: Hybrid**18 month fixed term contract**\nPosition Summary\nThe Senior Quality Systems Specialist is responsible for leading and executing quality system integration activities to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable global medical device regulations. This role focuses on evaluating, harmonizing, and integrating quality system processes, documentation and controls.\nKey Areas of Responsibility\nAssess and document current-state quality system processes, procedures, records, roles, responsibilities, and controls across both organizations.\nPerform process mapping and detailed gap assessments across applicable QMS processes, including CAPA, Complaints, Document Control, Training, Audits, Management Review, and other relevant quality system areas.\nEvaluate identified gaps against applicable regulatory requirements, corporate requirements, business needs, and the approved QMS integration strategy.\nSupport the definition and documentation of future-state processes, including process ownership, roles, responsibilities, interfaces, and required controls.\nDevelop, revise, and harmonize procedures, work instructions, forms, templates, and related quality system documentation to support the approved future-state QMS.\nPartner with process owners and subject matter experts to determine appropriate disposition of existing processes and documentation, including adoption, revision, consolidation, replacement, or retirement.\nIdentify compliance risks, process dependencies, implementation constraints, and potential business impacts associated with QMS integration activities.\nPartner cross-functionally with Manufacturing, R&D, Quality, Regulatory, and other business functions to implement sustainable and compliant integrated processes.\nSupport verification of QMS changes to confirm that approved requirements have been implemented and that the resulting processes are effective.\nFacilitate document review, approval, issuance, and retirement activities through the applicable electronic document management system.\nCollaborate with the Training Team and process owners to develop and implement training for new or revised procedures, roles, and compliance expectations.\nSupport the transition of applicable quality records, controlled documents, and other QMS content into the approved future-state systems and repositories.\nMaintain effective communication with project management, process owners, and key stakeholders regarding decisions, risks, resource needs, and roadblocks.\nEnsure integration activities maintain ongoing compliance with FDA requirements, ISO 13485, MDSAP, EU MDR, and other applicable regulatory and quality system requirements.\nSupport integration-related internal and external audits by providing accurate, complete, and retrievable documentation and objective evidence.\nQualifications\nLevel 6 qualification required, preferably in a Science, Engineering, Business or related discipline.\nMinimum of 3 years experience in manufacturing environment or equivalent preferred.\nExperience in regulated environment and interaction with regulatory agencies\nKnowledge\nUnderstanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.\nStrong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)\nExcellent technical writing and documentation skills.\nStrong communication and influencing skills.\nAbility to plan, organize, and implement multiple concurrent tasks.\nStrong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.\nAnalytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.\nDemonstrated ability to work in cross-functional team environments.\nSystem/Computer Requirements:\nBasic Microsoft Office, MS Project, Adobe Acrobat\nUnited Kingdom Pay Ranges:\n United Kingdom: £35,000 - £58,400 GBP Annual\nAt Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.\nIf you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.\nTravel Percentage: None","description_format":"text","description_chars":4758,"description_truncated":false,"requirements":{"experience_years_min":3,"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":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Hospital Equipment & Furniture"],"lifecycle":[{"event":"open","at":"2026-10-02T22:25:19Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Senior or Specialist Worker, Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Global Business Mobility: Senior or Specialist Worker; Skilled Worker","cap_exempt":false,"checked_at":"2026-10-27T06:21:15+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":40,"band":"fade","label":"Fading","p_open":0.9,"p_active":0.596,"p_room":0.75,"age_days":24,"expected_fill_days":32,"reasons":["conf:72","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":77284,"is_top_pay":false},"html_url":"https://alion.io/job/stryker-senior-quality-systems-specialist-integration","json_url":"https://alion.io/job/stryker-senior-quality-systems-specialist-integration.json","meta":{"generated_at":"2026-10-27T06:37:22Z","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":6870,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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-integration"},{"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-integration"},{"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-integration"},{"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-integration\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstryker-senior-quality-systems-specialist-integration"}]}