{"id":3268063,"url":"https://alion.io/job/intuitive-surgical-supplier-quality-engineer","title":"Supplier Quality Engineer","company":{"id":3128,"name":"Intuitive Surgical","domain":"intuitive.com","url":"https://alion.io/company/intuitive","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":75,"open_postings":73,"ghost_share":0,"stale_share":0.986,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-10-27T05:46:45Z"}},"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":["George Town, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":19000,"max_usd":42000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5668},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"Windows","optional":false}],"status":"live","first_seen_at":"2026-10-26T06:24:36Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-27T05:40:05Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Primary Function of Position\nThe Supplier Quality Engineer reports to the Manager, Global Supplier Quality and is responsible for ensuring compliance of Intuitive's Supplier Controls with applicable regulations and standards including ISO 13485:2016, MDSAP, and EU MDR. The SQE partners with cross-functional teams - Purchasing, Product Quality, Supplier\nDevelopment, and Supplier Engineering - to improve Supplier Controls Business Processes. Key functions include conducting key Supplier Audits as Lead Auditor, Supplier Monitoring Boards, managing Internal CAPAs related to supplier controls, driving high-visibility SCARs.\n Essential Job Duties\nConduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit\nSchedule, including Pre-Audit activities and Post-Audit actions.\nExecute Audit Reports with necessary Audit Response Forms and Supplier Responses.\nOwn Supplier Quality processes including Supplier Controls, Global Supplier Manual,\nSupplier Selection, Evaluation and Re-Evaluations, SCAR Process, and Supplier Monitoring as a Corporate Business Process Owner.\nRun quarterly Supplier Monitoring Boards with cross-functional stakeholders, presenting Supplier Quality health metrics on Audits, SCARs, Supplier nonconformances, and ASL.\nPeriodically analyze and review Supplier Controls processes in partnership with Regulatory Affairs/Quality Systems team to maintain compliance with latest applicable Regulations and Standards.\nLead internal CAPAs related to Supplier Controls.\nLead high-visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as Lead Auditor.\nGuide Process Managers on ASL maintenance and Supplier promotions and removals.\nSupport Internal and External Audits (FDA, MDSAP, EU MDR, etc.) representing Supplier Quality in Audit Front Rooms.\nLead Projects as Project Manager to improve Supplier Controls Processes for efficiency and compliance.\nServe as technical custodian of Supplier Data Monitoring and Analysis; analyze and prepare data for Supplier Monitoring Boards and monitor tools and dashboards for accuracy.\nReview and Approve Product SCARs; serve as board member for SCAR Review Boards.\nProvide guidance to International Intuitive Sites on Local/Regional Supplier Controls execution and maintenance.\nProvide guidance to NPI Project teams on Supplier Selection and onboarding.\nGuide Purchasing department on Quality elements of Supplier Agreement negotiations.\n Required Skills and Experience\nMinimum 3 years of related experience in Supplier Quality and/or Supplier Development or a related field.\nExcellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards.\nISO 13485 Lead Auditor Certification.\nAbility to work with highly technical teams and communicate effectively in an engineering-driven environment.\nStrong organizational, written, and verbal communication skills with proven ability to prioritize tasks in a deadline-driven environment.\nExcellent presentation skills, including executive-level management presentations.\nExcellent leadership and project management skills.\nSignificant computer experience using Windows, Word, Excel, Agile, Trackwise, SAP and basic AI prompts.\nAbility to read and interpret detailed mechanical drawings and communicate technical information.\nRequired Education and Training\nBS degree in Engineering or equivalent.\n Working Conditions\nAbility to travel to suppliers and other Intuitive sites on an as-needed basis (approximately 50%), both domestically and internationally.\n Preferred Skills and Experience\nMaster's degree in Engineering or related field.\nCertified Lead Auditor for EUMDR, QMSR.\n Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.\nWe will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.\nU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.\nCertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).\nFor any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.\nThis position may be filled at a different job level than listed here depending on\nbusiness need and/or on the selected candidate’s experience, knowledge and skills.\nCompensation will be based primarily on the job level at which the role is filled and the\ncandidate’s qualifications, consistent with applicable law.","description_format":"text","description_chars":5655,"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":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical & Healthcare Robotics"],"lifecycle":[{"event":"open","at":"2026-10-26T10:28:05Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":0,"expected_fill_days":29,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/intuitive-surgical-supplier-quality-engineer","json_url":"https://alion.io/job/intuitive-surgical-supplier-quality-engineer.json","meta":{"generated_at":"2026-10-27T09:36:50Z","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":10767,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":3128},"rest":"https://alion.io/mcp/rest/get_company?id=3128"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fintuitive-surgical-supplier-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%2Fintuitive-surgical-supplier-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%2Fintuitive-surgical-supplier-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/intuitive-surgical-supplier-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fintuitive-surgical-supplier-quality-engineer"}]}