{"id":3816597,"url":"https://alion.io/job/intuitive-surgical-sr-quality-engineer-3","title":"Sr. 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":60,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-11-06T05:58:05Z"}},"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":["Durham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-11-05T13:23:55Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-06T19:31:54Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion -have transformed how care is delivered for millions of patients worldwide.\nWe’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.\nThe problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.\nIf you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.\n Primary Function of Position\nThis position will report through the Professional Education and Program Services (PEPS) organization. This individual will be responsible for enabling the Advanced Tissue Models team to establish optimum quality control in product manufacturing and design control through implementation of key quality metrics and implementing actions to reduce defects and meet quality objectives.\nThe position will support design and development, material procurement, manufacturing, rework, and distribution of porcine-derived and synthetic surgical training tissue models as well as distribution of supporting equipment.\nEssential Job Duties\nInitial roles and responsibilities for this position will include the following:\n60% involvement in supporting new product development, 25% in sustaining manufacturing operations, and 15% quality advocacy and driving continuous improvements.\nProduct development:Strong contributor to the planning and execution of design controls, risk management, and design verification/validation for design changes for system and subsystems.\nParticipate in risk management process ensuring that risks are properly identified/assessed and risk management files are updated accordingly.\nEnsure design changes are established and implemented according to ISI standards and applicable regulations.\nRecommend design processes and methods to meet quality goals (DFX, etc.).\n\nManufacturing support:Support manufacturing processes, including failure analysis and defect/scrap containments.\nEnsure manufacturing activities follow procedures and comply with USDA regulations.\nSupport development and execution of process validation and verification test plans, protocols, and reports, as needed.\nMaintain site level process risk management files and update as required.\nSupport production ramp, work cross functionally on issues and drive continuous improvement projects.\nSupport investigation and disposition of defects, both internal and supplier related.\n\nQuality Advocacy:Develop and apply corporate-level quality metrics.\nEnsure the quality system requirements are effectively established and maintained.\nLead and manage quality initiatives in one or more areas of product and processes quality.\n\nContinuous Improvement:Review line non-conformance data and identify the trends and drive the continuous improvement projects including identifying the root cause, implementation and closure.\nReview data proactively and take actions to mitigate issues from occurring.\n\nSupport internal and external audits, including audit preparation, reviewing the front room documents and interacting with the auditors.\nPerform risk analysis and determine quality disposition for variance requests and non-conformances.\nApprove process and document changes through engineering change orders and deviations.\nEscalate issues/potential issues to direct management that could impact compliance, patient safety or surgical efficacy.\nEnsure successful, on-time completion of department projects, communicate constraints to direct management when successful project completion is at risk.\nPerform deep technical failure analysis based on the physics of failure.\nReview and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.\nPerforms other duties as assigned by management.\nRequired Skills and Experience\nDemonstrated proficiencies of 21 CFR 820, ISO 13485 and ISO 14971 requirements for making process or design changes.\nUnderstands product risk management, experience in generating/updating FMEAs.\nUnderstands Design Controls, Change Controls, Product, and Engineering Processes.\nProficient with generation and execution of Qualifications, Validation protocols and Quality Assurance Procedures.\nExperienced in leading root cause analyses, product containment, and rework activities.\nProficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).\nUnderstands typical Excel data analysis operations (e.g. Pareto, charts, and trends).\nCapable of thinking independently and making decisions based on limited information.\nAbility to communicate effectively both verbally and in writing.\nAccepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when dealing with others\nAbility to work independently and handle tasks with competing priorities effectively.\nRequired Education and Training\nBachelor’s degree in Engineering, Mathematics, Physics, Life Sciences, or related discipline. Advanced degree preferred.\nMinimum of 8 years (or minimum 6 years with advanced degree) of experience in Quality Engineering within a manufacturing environment, including at least 4 years in the medical device industry.\n Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.\nIntuitive is an Equal 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.\nMandatory Notices\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.\nWe will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.\nPreference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.\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.\nAccommodation & Accessibility Notice:\nIntuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at .\nWe provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. 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