{"id":2359027,"url":"https://alion.io/job/medtronic-quality-engineer-ii-17","title":"Quality Engineer II","company":{"id":638,"name":"Medtronic","domain":"medtronic.com","url":"https://alion.io/company/medtronic","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":91,"open_postings":149,"ghost_share":0.04,"stale_share":0.376,"repost_share":0.154,"time_to_fill_p50_days":19,"computed_at":"2026-11-04T06:34:25Z"}},"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":"explicit","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"IEC 60601","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Minitab","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-12T15:28:35Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-11-04T11:22:16Z","board_verified":true,"closed_at":null,"days_open":23,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":23},"description":"Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.\nA Day in the Life\nThe Quality function partners with Research & Development and Operations teams to ensure medical devices are designed, developed, and maintained in compliance with applicable quality system regulations, risk management requirements, and international standards. The team provides quality engineering leadership throughout the product lifecycle, supporting design controls, verification and validation activities, risk management, product transfers, regulatory compliance, and continuous quality improvement initiatives.This position is based in Hyderabad, India and follows a Flex work arrangement. No travel is required.\nAs a Quality Engineer II, you will provide design quality engineering support for medical device product development and sustaining engineering activities. The role is responsible for facilitating the application of design controls, risk management, design verification and validation, and regulatory compliance activities while partnering with cross-functional teams throughout the product lifecycle.\nPrimary Responsibilities\nReview new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.\nEnsure product development projects and design changes comply with FDA Quality System Regulations, European Union Medical Device Regulation (EU MDR), and internal quality requirements.\nPartner with cross-functional teams to develop and maintain risk management documentation, including Risk Management Plans, Hazard Analyses, Design Failure Mode and Effects Analysis (DFMEA), and Risk Management Reports in accordance with ISO 14971.\nSupport design verification and validation activities through development and review of plans, protocols, reports, testing strategies, and compliance assessments.\nReview Design History Files (DHF) and Technical Files for compliance with applicable regulations, standards, and quality requirements.\nSupport successful transfer of products into manufacturing through process validation activities, including Process Failure Mode and Effects Analysis (PFMEA), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).\nDevelop quality system templates, training materials, and guidance related to design controls, risk management, quality system regulations, and applicable standards.\nParticipate in internal and external audits and provide quality engineering guidance across project teams and organizational functions.\nRequired Qualifications\nBachelor's degree in Mechanical Engineering with 5+ years of overall experience, including 3+ years of quality engineering experience in medical device, regulated manufacturing, or healthcare industries.\nExperience with medical device Design Controls, Risk Management, and product development activities.\nExperience supporting ISO 14971 risk management activities, including Risk Management Plans, Hazard Analyses, and Design Failure Mode and Effects Analysis (DFMEA).\nKnowledge of FDA Quality System Regulation, ISO 13485, EU MDR, IEC 60601, 21 CFR Part 820, and 21 CFR Part 11.\nExperience using statistical tools and methodologies, including Minitab, sampling plans, hypothesis testing, Analysis of Variance (ANOVA), Gauge Repeatability and Reproducibility (GR&R), and related statistical techniques.\nPreferred Qualifications\nASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), or Certified Reliability Engineer (CRE) certification.\nISO 9001 or ISO 13485 Internal Auditor or Lead Auditor certification.\nLean Six Sigma Green Belt or Black Belt certification.\nExperience with DMAIC or Design for Six Sigma (DFSS)/DMADV methodologies.\nExperience acting as a Risk Management or Design Quality subject matter expert within cross-functional product development teams.\nPhysical Job Requirements\nThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.\nRecruitment Fraud Alert\nWe are aware of phishing scams targeting job seekers. Please keep the following in mind:\nApply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.\nMedtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.\nIf you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.\nIf you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at .\nBenefits & Compensation\nMedtronic offers a competitive Salary and flexible Benefits Package\nA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.\nThis position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).","description_format":"text","description_chars":5899,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-10-12T15:28:35Z"}],"visa":[],"liveness":{"score":50,"band":"ok","label":"Likely open","p_open":1,"p_active":0.903,"p_room":0.55,"age_days":22,"expected_fill_days":19,"reasons":["conf:0","wave","velocity","win:tail","comp:brand"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/medtronic-quality-engineer-ii-17","json_url":"https://alion.io/job/medtronic-quality-engineer-ii-17.json","meta":{"generated_at":"2026-11-04T16:30:56Z","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":25192,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":638},"rest":"https://alion.io/mcp/rest/get_company?id=638"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmedtronic-quality-engineer-ii-17"},{"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%2Fmedtronic-quality-engineer-ii-17"},{"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%2Fmedtronic-quality-engineer-ii-17"},{"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/medtronic-quality-engineer-ii-17\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmedtronic-quality-engineer-ii-17"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2359027}},{"tool":"search_jobs","arguments":{"company":"medtronic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2359027},"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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