{"id":3525986,"url":"https://alion.io/job/align-technology-qms-engineer","title":"QMS ENGINEER","company":{"id":678151,"name":"Align Technology","domain":"aligntech.com","url":"https://alion.io/company/align-tech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Pinpoint","truth_index":{"grade":"A","score":100,"open_postings":9,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":16,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":1708329,"max":2220828,"currency":"INR","period":"year","gross":null,"usd_annual":23521},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-10-29T14:08:31Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-05T23:00:10Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"This position is ideal for quality and compliance professionals to join the QARA team as a QMS Engineer, supporting manufacturing operations and ensuring the effectiveness of the Quality Management System. Partnering with manufacturing and cross-functional teams, you’ll drive quality improvement initiatives, CAPA management, audits, complaint handling, risk assessments, and document control processes. This role is critical in maintaining regulatory compliance, enhancing process quality, and supporting continuous improvement across the organization.\nKey Responsibilities\n\nIdentify, analyze, and lead continuous improvement initiatives focused on enhancing process and product quality and exceeding customer expectations. • Support internal and cross-functional teams in quality improvement and process optimization activities. • Ensure quality documentation is established, maintained, implemented, and continuously improved to meet business and regulatory requirements.\nCoordinate complaint handling activities and lead root cause investigations for quality-related issues.\nWork with cross-functional stakeholders to investigate non-conformances, implement corrective actions, and monitor CAPA effectiveness.\nConduct and participate in risk assessments related to products, processes, and designs.\nSupport corporate and external agency inspections related to the Quality Management System.\nConduct and participate in internal and supplier audits to ensure Quality Management System compliance.\nEnsure appropriate quality controls are implemented and maintained within manufacturing processes.\nServe as a subject matter expert for quality systems and quality process improvement projects.\nGuide, coach, and support process owners and stakeholders on quality-related requirements and best practices.\nEnsure timely achievement of assigned quality objectives, deliverables, and project deadlines.\nMaintain site document control procedures in compliance with regulatory requirements and internal policies.\nManage site change control activities within the EDMS, including review of change control documentation and deliverables.\nReview documentation, document archives, procedures, translations, and change control records to ensure accuracy and compliance.\nSupport administration and maintenance of the electronic document management system (EDMS).\nCreate and maintain active and archival documentation records for controlled documents.\nSkills, Knowledge & Expertise\n\nEducation: Bachelor’s degree in Chemistry, Engineering, Quality, or a related field required; postgraduate studies in Quality Management preferred.\nExperience: Minimum 3+ years of experience in a quality or compliance role within medical devices or other regulated industries. Solid understanding of Quality System regulations including 21 CFR, ISO 13485, MDR 2017/745, and GMP.\nSkills: Practical knowledge of quality problem-solving tools, production processes, validation methods, statistics, Minitab, SPC, ISO 13485, and Microsoft Office applications including MS Project.\nCommunication: Strong written and verbal communication skills with the ability to effectively synthesize and present information. Fluent English communication skills required.\nTeamwork: Ability to collaborate effectively with cross-functional teams, build strong working relationships, work independently, and perform successfully in a fast-paced environment.\nComplementary skills\n\nBlack Belt or Green Belt certification preferred.\nISO 13485 Internal Auditor certification preferred.\nExperience with CAPA, complaint handling, risk management, audits, document control, and quality system compliance activities.\nStrong interpersonal, organizational, and project follow-through skills with the ability to work under pressure and adapt to changing priorities.","description_format":"text","description_chars":3801,"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":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dental Products & Labs"],"lifecycle":[{"event":"open","at":"2026-10-30T14:08:31Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.902,"p_room":0.9,"age_days":6,"expected_fill_days":16,"reasons":["conf:3","velocity","win:mid","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":23521,"is_top_pay":false},"html_url":"https://alion.io/job/align-technology-qms-engineer","json_url":"https://alion.io/job/align-technology-qms-engineer.json","meta":{"generated_at":"2026-11-06T01:40:24Z","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":2769,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":678151},"rest":"https://alion.io/mcp/rest/get_company?id=678151"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falign-technology-qms-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%2Falign-technology-qms-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%2Falign-technology-qms-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/align-technology-qms-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falign-technology-qms-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3525986}},{"tool":"search_jobs","arguments":{"company":"aligntech.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3525986},"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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