{"id":1596825,"url":"https://alion.io/job/stryker-senior-advance-quality-engineer","title":"Senior Advance 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":"A","score":85,"open_postings":171,"ghost_share":0,"stale_share":0.602,"repost_share":0.018,"time_to_fill_p50_days":24,"computed_at":"2026-10-17T05:46:00Z"}},"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":["Gurgaon, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":11500,"max_usd":32000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":23},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Azure DevOps","optional":false},{"name":"Jira","optional":false},{"name":"TestRail","optional":false},{"name":"Agile","optional":true},{"name":"Azure","optional":true}],"status":"live","first_seen_at":"2026-10-01T18:11:50Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-17T20:29:18Z","board_verified":true,"closed_at":null,"days_open":16,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":16},"description":"Work Flexibility: HybridWhat you will do-\nServe as the Quality representative on New Product Development (NPD) and sustenance engineering projects.\nDefining the quality and compliance requirements for development of SaMD and ensuring the requirements are communicated to the stakeholders and met.\nDevelopment of process and procedures for development, testing and deployment of SaMD or Non Med SW and ensure software development activities comply with established SDLC processes.\nParticipate in requirements, architecture, design, code, verification, and validation reviews and drive risk management activities including software hazard analysis and FMEA reviews.\nReview and Approve quality deliverables required throughout the development lifecycle; requirements for traceability, completeness, and testability and E2E test coverage and compliance.\nDevelop and execute software quality strategies, test plans, and validation approaches.\nEnsure appropriate verification and validation activities are performed and documented.\nEnsure compliance with industry standards and regulations (e.g., ISO 13485, FDA regulations, IEC 62304, cybersecurity requirements, company quality procedures).\nSupport internal and external audits and ensure the SW bugs (pro-prod and prod) and properly addressed and review CAPAs, non-conformances, deviations, and change controls related to software products.\nValidation of SW tools used in development, testing and deployment.\nEnsuring the deployment compliance per customer requirements in collaboration with R&D and deployment teams.\nMaintain Design History File (DHF) and software quality documentation\nPartner with Software Engineering, Systems Engineering, Product Management, Regulatory Affairs, Clinical Affairs, and Manufacturing teams and provide guidance on software quality best practices.\nMentor junior quality engineers and support organizational capability building\nWhat you will need-\nRequired Skills-\nExperience on Medical Device Development process; New Product Development process and various phases of new product development; experience on Risk Management, different Risk Analysis tools and techniques and experience on ISO 14971\nUnderstanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001) and well versed with change control process\nExperience in following technical areas is recommended - Software Development Life Cycle (SDLC); Risk Management / FMEA; Verification & Validation (V&V); Defect Management Systems (Jira, Azure DevOps, etc.); Requirements Traceability; Root Cause Analysis (RCA); Cybersecurity and Product Security concepts and change control process; Jira, Testrail, TrackWise, Salesforce, slack\n Education- Bachelor's degree in Computer Science, Software Engineering, Electronics Engineering, Biomedical Engineering, or related discipline/ Master's degree preferred\nExperience- 5 years- 7 years; 4 years in relevant Software Quality Assurance, Software Engineering, or Quality Engineering.\nExperience working in regulated environments (Medical Devices, Healthcare Software, Automotive, Aerospace, etc.).\nPreferred Skills-\nShould be ready to travel to divisions as required.\nEffective interpersonal, communications skills.\nGood understanding of Agile and traditional SDLC methodologies\nTravel Percentage: 10%","description_format":"text","description_chars":3293,"description_truncated":false,"requirements":{"experience_years_min":7,"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","Hospital Equipment & Furniture"],"lifecycle":[{"event":"open","at":"2026-10-01T18:11:50Z"}],"visa":[],"liveness":{"score":50,"band":"ok","label":"Likely open","p_open":1,"p_active":0.559,"p_room":0.9,"age_days":15,"expected_fill_days":24,"reasons":["conf:2","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/stryker-senior-advance-quality-engineer","json_url":"https://alion.io/job/stryker-senior-advance-quality-engineer.json","meta":{"generated_at":"2026-10-18T01:10:26Z","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":1948,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-19T00:00:00Z"}},"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-advance-quality-engineer"},{"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-advance-quality-engineer"},{"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-advance-quality-engineer"},{"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-advance-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstryker-senior-advance-quality-engineer"}]}