{"id":1139639,"url":"https://alion.io/job/stryker-senior-quality-engineer-complaints-handling-2","title":"Senior Quality Engineer - Complaints Handling","company":{"id":2579,"name":"Stryker","domain":"stryker.com","url":"https://alion.io/company/stryker","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":85,"ghost_share":0,"stale_share":0.776,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-09-23T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"hiring_geo_confidence":"structured","locations":["Gurgaon, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-23T10:13:53Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-23T09:51:51Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Work Flexibility: HybridWhat you will do:\nComplaint handling and Product investigations of medical devices\nPerform Visual, functional, dimensional, functional inspection & RCA of field returned products.\nMaintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.\nRisk management -Risk assessment\nReview of Process flow, DHR, Inspection plans, Measurement techniques, Review NC and CAPA and be able to identify any occurrence of an NC.\nReview and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints\nCreate PMS plan, PMS report, PSUR report as per EUMDR guidelines, Trend report & Complaint analysis.\nProvide technical guidance and promote quality best practices across the organization.\nIdentify and lead opportunities for process improvement, redesign, and development of workflows.\nHold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities. Mentor, develop and inspire others in current and future roles.\nOther tasks as assigned by manager.\nWhat you need:\nRequired:\nB. Tech / M.Tech Mechanical, Biotechnology with hands on experience of Complaint handling and product investigations process; problem-solving methodology, root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability, and engineering drawing.\nHands on experience of Risk Management process as per ISO 14971.\nExperience - 5years -7years\nSound knowledge on complaint handling process of medical devices will be an added advantage.\nApplied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have).\nAbility to collaborate and influence within matrix organizations and engage effectively with multiple stakeholders across multi-national teams.\nPreferred:\nDemonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies; ability to self-motivate, ability to prioritize tasks in a deadline-driven environment.\nDemonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams and mentor and lead a group of individuals towards meeting buisness needs and set them up for future success.\nTravel Percentage: 20%","description_format":"text","description_chars":2355,"description_truncated":false,"requirements":{"experience_years_min":null,"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":["Health Care"],"lifecycle":[{"event":"open","at":"2026-09-23T10:13:53Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":26,"reasons":["conf:3","win:early","comp:brand"],"computed_at":"2026-09-23T13:55:20Z"},"pay":null,"html_url":"https://alion.io/job/stryker-senior-quality-engineer-complaints-handling-2","json_url":"https://alion.io/job/stryker-senior-quality-engineer-complaints-handling-2.json","meta":{"generated_at":"2026-09-23T13:55:20Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}