{"id":3543938,"url":"https://alion.io/job/boston-scientific-quality-systems-engineer-ii-capa","title":"Quality Systems Engineer II - CAPA","company":{"id":1758528,"name":"Boston Scientific","domain":"bostonscientific.com","url":"https://alion.io/company/bostonscientific-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Eightfold","truth_index":{"grade":"B","score":79,"open_postings":69,"ghost_share":0.058,"stale_share":0.638,"repost_share":0.087,"time_to_fill_p50_days":33,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Maple Grove, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":71500,"max":null,"currency":"USD","period":"year","gross":null,"usd_annual":71500},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-09-15T18:12:48Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-03T10:24:14Z","board_verified":true,"closed_at":null,"days_open":48,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":48},"description":"Recruiter: Spencer Gregory Hale\nQuality Systems Engineer II\nAbout the role:\nAs a Quality Systems Engineer II, you will support the Corrective and Preventative Action (CAPA) process at Maple Grove, inclusive of nonconforming events.\nThe Quality Systems Engineer II will support compliance of the CAPA Process to internal requirements and external regulations. This includes CAPA Investigations and Product/Material/System Nonconformances. This role partners closely with Maple Grove CAPA team members, investigation owners, and site leadership. They will provide mentorship to Quality team members and cross-functional stakeholders to enable high-quality investigations, robust root cause identification, and sustainable corrective and preventive actions.\nWork model, sponsorship, relocation:\nAt Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.\nYour responsibilities will include:\nMentor cross-functional CAPA teams on:\n- root cause analysis, corrective action plans, and effectiveness verifications\n- using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet critical CAPA phase timelines\n- creating robust, compliant, and timely records, using the electronic CAPA database system\nProvide guidance on nonconformance investigations to support appropriate scoping, risk assessments, corrections, and material/product containment (including physical segregation/identification).\nProvide continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements\nApply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues\nActs as an effective team member and/or leader in supporting quality disciplines, decisions, and practices\nPartner with cross-functional stakeholders to drive standardization and adoption of best practices across sites\nTeam member of subject matter experts relating to CAPA at the Maple Grove site\nTrack actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program\nSupport Site, Regional, and Global CAPA initiatives, continuous improvement opportunities and/or projects\nDrive continuous improvement and efficiencies to support a preventive quality culture\nQualifications:\nRequired qualifications:\nBachelor's degree\nMinimum of 2 years' experience in the medical device or pharmaceutical industry\nPractical understanding of nonconformance and CAPA regulatory requirements and best practices\nUnderstanding of regulations/standards such as 21 CFR 820 and ISO 13485\nExperience leading or supporting cross-functional initiatives or projects\nStrong problem-solving and root cause analysis skills\nStrong communication and stakeholder management skills\nAbility to make sound, risk-based decisions\nPreferred qualifications:\nMinimum of 2 years' experience in Quality Systems and/or CAPA Management\nStrong interpersonal skills with the ability to collaborate effectively across Quality, Manufacturing, Engineering, Regulatory, and Supply Chain functions\nHigh attention to detail, organizational skills, and a disciplined approach to compliance and documentation\nAbility to prioritize tasks effectively in a deadline-driven environment\nProactive problem solver with a continuous improvement mindset\nAbility to manage priorities in a fast-paced environment with strict regulatory timelines\nHands-on Project Management experience\nAble to work independently and as a contributing team member\nContinuous improvement mindset with a passion for Quality\nRequisition ID: 634838\nMinimum Salary: $ 71500\nMaximum Salary: $ 135800\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com- will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.\nCompensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).\nCompensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\nBoston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.\nAmong other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. 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