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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality System Engineer III - **Company:** Boston, Inc. - **Location:** Maple Grove, MN, United States - **Experience:** Experienced - **Salary:** $78,300.0 - $148,800.0 - **Contract:** Permanent contract - **Skills:** Audit Trail, Bioinformatics, Maple Software - **Published:** August 20, 2026 - **Apply:** https://jobs.localjobnetwork.com/apply/add/88089199/1 ## About the Role * Bachelor's degree * Minimum of 3 years of relevant quality engineering experience in the medical device or pharmaceutical industry * Minimum of 1 year experience in a role that includes auditing * Understanding of regulations/standards applicable to BSC Quality Management (such as 21 CFR 820 and ISO 13485) * Conceptual, practical, and functional knowledge of quality principles, with a general understanding of related job functions * Strong verbal and written communication, including technical writing, and organizational skills * Detail oriented with the ability to analyze information quickly * Able to use a risk-based approach for making quality and business decisions Preferred Qualifications: * 3+ years of experience in audit execution (such as Internal Audits, Supplier Audits, or Regulatory Audits) * ASQ Certified Quality Auditor * Proactive, able to work independently with minimal supervision, as a team leader or member * Ability to collaborate and communicate with all levels of the organization * Continuous improvement mindset with a passion for Quality * Proven ability to influence without authority in a matrixed organization * Strong networking skills to foster collaborative relationships ## Description The Quality System Engineer III will serve as a Quality representative to provide support of quality initiatives and goals at a departmental, site, and regional level. This role will support Audit Excellence at Maple Grove, specifically focusing on the Internal Audit program to ensure the compliance and effectiveness of the BSC Quality Management System against external regulations/standards and BSC procedures., * Execute Internal Audits of the Maple Grove Site as assigned + Audits may include: Production, Design, Regulatory, Management Controls, and CAPA + Evaluate and document the compliance of assigned areas via: Tours, Interviews, Documentation and Record Review + Formulate and document nonconformities and opportunities for improvement + Understand procedures and evaluate compliance to applicable requirements * Lead Internal Audits + Collaborate cross-functionally with Audit Area Management for audit scheduling, execution, and initiation of audit nonconformities + Develop an Audit Plan, including scope, objectives, criteria, and planned schedule + Facilitate Audit Opening and Closing Meetings + Provide work directions to Audit Team + Complete Audit records, including Audit Report and Audit Trails + Communicate audit progress and results to Auditees and Leadership * Support and lead Internal Audit initiatives, continuous improvement opportunities, and/or projects + Coordinate activities, communicate progress, collaborate on key deliverables, and influence action. + Make pragmatic, risk-based decisions and provide input regarding how to apply requirements and best practices for processes compliance, efficiency, and effectivity. * Serve as a Quality System Expert resource as requested + Support External Audit readiness and execution, including performing production line walks and documentation review. + Partner cross-functionally to provide guidance on BSC's Quality Management system and external regulations/standards., Boston 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. Among other requirements, Boston Scientific maintains specificprohibited substancetest 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. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. 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