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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Quality Systems Engineer - **Company:** Boston, Inc. - **Location:** Maple Grove, MN, United States - **Experience:** Expert - **Salary:** $89,200.0 - $169,500.0 - **Contract:** Permanent contract - **Skills:** System Configuration, Document Management Systems, Strategies of Testing, Web Platforms - **Published:** June 11, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=6bd0f60c9c455122 ## About the Role Do you have experience in ISO standards?, * Minimum of Bachelor's degree in Engineering, quality, life sciences or a related field. * Minimum 5 years' experience in quality systems within a regulated industry * Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control processes, including ISO 13485, 21 CFR Part 820 and EU MDR. * Demonstrated experience partnering with cross-functional stakeholders to support quality system processes and digital tools * Previous experience or open to learning digital product ownership, quality systems application support and/or IT project experience, * Medical device industry experience preferred * Prior document control and records management experience preferred * Proven experience supporting audits, inspections and CAPA activities ## Description Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day., Global quality process and compliance ownership * Execute assigned process ownership responsibilities within a global governance framework while collaborating with global process stewards who provide compliance oversight. * Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR. * Participate in process monitoring, documentation updates, regulatory implementation activities and issue resolution to maintain a permanent state of compliance. Digital quality systems and IT partnership * Serve as a quality systems subject matter expert and business partner for digital platforms supporting document and records control processes. * Collaborate with IT and cross-functional stakeholders to support system configuration, enhancements, issue resolution and lifecycle management activities. * Partner with IT to translate business and regulatory requirements into technical solutions, validation activities and testing strategies. * Support root cause investigations, incident management and timely resolution of system-related issues to minimize business disruption. Continuous improvement and operational excellence * Lead continuous improvement initiatives using structured methodologies, including VIP, to drive efficiency, scalability and operational excellence. * Identify, analyze and resolve quality system issues using systematic problem-solving methodologies. * Drive process enhancements that strengthen quality culture and improve overall system effectiveness. Quality events, CAPA and risk management * Serve as an owner or lead contributor for nonconformance, exception and CAPA activities. * Support root cause analysis, corrective and preventive action planning, implementation and effectiveness verification. * Contribute to risk management activities and systemic issue resolution efforts. Project leadership and global collaboration * Lead or support complex global quality system projects, including process implementations, business transfers and acquisition integrations. * Contribute to the global quality systems roadmap and support alignment with organizational commitments and priorities. * Participate in and lead Communities of Practice activities to promote standardization and adoption of best practices. Audit and regulatory support * Serve as an audit-facing subject matter expert for assigned quality processes and digital quality systems. * Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities. * Develop training materials, audit support documentation and related compliance resources. Leadership, mentorship and training * Mentor and support Quality Systems Engineers while contributing to team capability development. * Deliver training on quality system processes, digital tools and applicable regulatory requirements. * Support broader departmental and Quality Systems initiatives as business needs require. ## Related Videos - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Your Testing Strategy is broken - lets fix it!](https://www.wearedevelopers.com/videos/1672-your-testing-strategy-is-broken-lets-fix-it) - [Enterprise Linux as Container Images](https://www.wearedevelopers.com/videos/1610-enterprise-linux-as-container-images) - [Project Fugu: Extending the web](https://www.wearedevelopers.com/videos/832-project-fugu-extending-the-web) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Testing .NET applications a Tool box for every developer](https://www.wearedevelopers.com/videos/704-testing-net-applications-a-tool-box-for-every-developer) ## Related Articles - [Best Companies to work for in London: Top 25 Companies in 2023](https://www.wearedevelopers.com/magazine/187-best-companies-to-work-for-in-london-top-25-companies-in-2023) - [Software Engineer Salary London](https://www.wearedevelopers.com/magazine/252-software-engineer-salary-london) - [Best Companies to Work For in Berlin: Top 14 Companies in 2023 ](https://www.wearedevelopers.com/magazine/188-best-companies-to-work-for-in-berlin-top-14-companies-in-2023) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs)