{"id":3314237,"url":"https://alion.io/job/medtronic-senior-quality-engineer-10","title":"Senior Quality Engineer","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":"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":["Kulim, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":15500,"max_usd":34000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":8444},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"Design History File","optional":true}],"status":"live","first_seen_at":"2026-10-27T04:30:27Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-04T11:22:16Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"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\nA career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life-a commitment that provides life-transforming technologies that treat more than 70 health conditions across cardiovascular, neuroscience, and surgical care. In 2025 our products and therapies treated more than 75M people - that’s two people every second of every hour, of every day.\nTogether, we can change healthcare worldwide which is why we’re embarking on a new venture in Malaysia and want you to be a part the next generation of life-changing medical technology to patients worldwide by being a part of our next chapter of innovation in Malaysia.\nMedtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting commitment to our new venture in Malaysia.\nIn this exciting role as a Senior Quality Engineer, you will be responsible for driving the transfer of manufacturing processes and products from our established facility to the new manufacturing site. While you will ensure that quality standards and protocols are effectively applied and maintained throughout the transfer process, aligning with ISO 13485 requirements and the company’s Quality Management System (QMS), you will have the unique and amazing opportunity to be a team player in a global team applying design flow down and transfer experience.\nThis role requires strong technical judgment and ownership of quality strategy during manufacturing transfer. You will be reporting to the Senior Quality Manager and works closely within a cross-functional team including design and research, engineering, manufacturing, legal manufacturers, and supply chain to ensure successful and compliant manufacturing transfers.\nThis position is based fully on-site at our new local facility. International travel of +25% may be required during the transfer project interacting with the sending site team and supporting key transfer activities at both sending and receiving sites.\nPrimary Responsibilities:\nProvide technical guidance and mentorship to junior quality engineers and cross-functional teams throughout the transfer process.\nDevelop, modify, apply, and maintain quality standards and protocols for transferring products and manufacturing processes, ensuring compliance with ISO 13485:2016 and the company’s Quality Management System (QMS).\nCollaborate with cross-functional teams including engineering, manufacturing, regulatory, supply chain, and suppliers to integrate quality requirements into all phases of the transfer plan, from process setup through production handover.\nDefine and implement inspection methods, sampling plans, and quality controls for transferred processes, including in-process and final inspection stages.\nSupport Test Method Validation (TMV), process validation activities (IQ/OQ/PQ), ensuring protocols, acceptance criteria, and documentation meet regulatory and QMS requirements.\nEnsure quality engineering activities for NPI manufacturing transfer are compliant with quality requirements, including traceability of DOTM, process validations, etc.\nDevelop and maintain process risk management documentation (PFMEA, control plans) to identify, mitigate, and monitor process risks during transfer and production ramp-up.\nCoordinate readiness of manufacturing equipment, tooling, and inspection systems to support process qualification and production start-up.\nWork with the sending site and local teams to collect and analyze historical quality data, defect trends, and process capability information to proactively address known risks before production launch.\nParticipate in readiness reviews, special builds, and verification activities to ensure process capability, product quality, and yield targets are met.\nReview and manage quality issues (e.g. nonconformances) during transfer builds, ensuring timely closure, root cause analysis, and escalation into CAPA when required.\nEnsure audit readiness by maintaining complete, accurate, and compliant records for validation, inspection, and risk management activities.\nApply continuous improvement principles and implement structured problem-solving tools to drive issue resolution, waste elimination, and process optimization throughout the product transfer lifecycle.\nFocus on enhancing process stability, improving efficiency, and sustaining high-quality output post-transfer.\nEncourage a culture of First Time Quality at the Source, emphasizing preventive and predictive approaches to minimize defects and ensure compliance from the start.\nRequired Qualifications:\nA university degree in engineering (biomedical, chemical, industrial, biotechnology, or related fields) is required and minimum of 6 years of relevant experience.\nExperience in regulated industries such as medical devices, pharmaceuticals, or biotechnology is necessary.\nProficiency in preparing and reviewing technical documentation, including protocols, reports, and validations, is essential.\nKnowledge of ISO 13485 quality management system requirements must be demonstrated.\nA good understanding of Good Manufacturing Practices (GMP) is important.\nIntermediate to advanced English skills, especially for reading and writing technical documents, are needed.\nClear verbal and written communication abilities are required.\nExperience with creating and maintaining SOPs, protocols, and technical reports is essential.\nWillingness to travel as per job requirements is necessary.\nHolding a valid passport for travel purposes is mandatory.\nWillingness to undertake extended overseas assignments of one month or more, if needed, is expected.\nPreferred Qualifications:\nExperience working with cross-functional teams such as production, quality, regulatory, and engineering adds value.\nParticipation in at least one technology or process transfer project is expected.\nParticipation in regulatory audits is considered beneficial.\nKnowledge of process validation activities including IQ/OQ/PQ is preferred.\nExperience in transferring production lines would be advantageous.\nFamiliarity with product design documents, device master records (DMR), and design history files (DHF).\nExperience using quality management systems (QMS), managing CAPAs, and handling change control.\nImmediate availability or the ability to join within a short notice period is preferred.\nPrevious experience collaborating with external teams from different countries.\nCultural adaptability and experience working in multicultural environments will be valued.\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":8685,"description_truncated":false,"requirements":{"experience_years_min":6,"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":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-10-27T04:30:27Z"}],"visa":[],"liveness":{"score":89,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.986,"p_room":0.9,"age_days":8,"expected_fill_days":19,"reasons":["conf:0","wave","velocity","win:mid","comp:brand"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/medtronic-senior-quality-engineer-10","json_url":"https://alion.io/job/medtronic-senior-quality-engineer-10.json","meta":{"generated_at":"2026-11-04T16:31:52Z","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":25205,"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-senior-quality-engineer-10"},{"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-senior-quality-engineer-10"},{"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-senior-quality-engineer-10"},{"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-senior-quality-engineer-10\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmedtronic-senior-quality-engineer-10"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3314237}},{"tool":"search_jobs","arguments":{"company":"medtronic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3314237},"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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