> Markdown version of [/jobs/ext/1536461-sr-quality-systems-engineer](https://www.wearedevelopers.com/jobs/ext/1536461-sr-quality-systems-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Quality Systems Engineer - **Company:** Sirtex Medical - **Location:** Woburn, MA, United States - **Experience:** Expert - **Salary:** $94,000.0 - $119,000.0 - **Contract:** Permanent contract - **Skills:** Microsoft Excel, Data Visualization, Failure Mode Effects Analysis, Power BI, Tableau (Software), Workflow Management Systems, Trackwise, Veeva, Mdsap, VeevaVault, User Administration - **Published:** July 2, 2026 - **Apply:** https://jobs.localjobnetwork.com/apply/add/87616977/1 ## About the Role * Bachelor's degree or higher in Engineering, Life Sciences, ora relatedtechnical field required * 5+ years of experience in Quality Systems within the medical device, pharmaceutical, or biotech industries required * Proven experience administering andoptimizingeQMSplatforms (e.g., Veeva Vault,MasterControl, ETQ,TrackWise), including workflow configuration and governance required. * Strong analytical capability with experience developing metrics, trending quality data, and driving data-based decision making. * Strong working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, MDSAP, and global regulatory requirements required. * Ability to work independently, prioritize effectively, and leadcomplex projects, implementation, and continuous improvement of QMS processes and SOPs. * Strong problem-solving and root cause analysis skills (e.g., using tools such as 5 Whys, Fishbone, FMEA). * Excellent written and verbal communication skills with the ability topresent toexecutive leadership and external auditors. * Detail-oriented with a strong compliance mindset and ability to ensure audit-ready documentation. Preferred Qualifications * Advanced degree (MS, MBA) in a technical or related field. * ASQ certification (e.g., CQE, CQA) or equivalent professional certification. * Direct experience with Veeva VaultQualityDocsor similar cloud-basedeQMSplatforms. * Background in data visualization and tools (e.g., Power BI, Tableau, advanced Excel). * Experience leading QMS transformation, harmonization, or integration efforts (e.g., post-acquisition environments). * Familiarity with risk management principles per ISO 14971 and integration with quality system processes. ## Description The Senior Quality Systems Engineeris responsible formaintaining, improving, and ensuring complianceofthe Quality Management System (QMS) in alignment with applicable medical device regulations (e.g., FDA QMSR/21 CFR Part 820, ISO 13485, MDSAP). This roleoperatesindependently, leadscross-functional quality initiatives, and drives continuous improvement across quality systems processes, including CAPA, Nonconformance (NCR), audits, and Management Review. The position also serves as a key administrator and subject matter expert for the electronic QMS (eQMS)., * Maintain and administer the Quality Management System in full conformance with applicable regulatory standards, including 21 CFR Part 820,ISO 13485MDSAP, EUMDR, and QMSR. * Proactivelyidentifysystemic gaps, develop improvement initiatives, and drive implementation through cross-functional collaboration. * Serve as an internal authority on quality system requirements, providing guidance and interpretation to functional teams. * Administer andmaintainthe electronic Quality Management System (eQMS), including configuration, user management, workflow design, and ongoing optimization. * EnsureeQMSsystem validation status ismaintained; coordinate system updates and manage associated change control activities. * Develop,maintain, and analyze quality system metrics and key performance indicators (KPIs) toidentifytrends, assess system performance, and support data-driven decision-making. * Prepare and present quality data summaries and trend analyses for leadership and regulatory audiences. * Provide guidance forthe end-to-end Corrective and Preventive Action (CAPA) and Nonconformance Report (NCR) processes, ensuringtimelyinitiation,appropriate containment, robustroot cause analysis,risk-basedcorrective actions, and documented verification of effectiveness. * Providetechnical guidance to cross-functional teams in problem-solving methodologies and documentation requirements. * Plan, coordinate, and execute the internal audit program, including scheduling, conducting audits, and managing findings throughclosure. * Supportexternal regulatory inspections and notified body audits; coordinate auditlogisticsand manageresponse activities. * Responsible for providingquality system inputsand documentation andtrackingoutputs and action itemsfor theManagement Review process. * Ensure Management Review activities meet regulatory requirements and are completed on a defined schedule. * Lead cross-functional initiatives to enhance QMS effectiveness, efficiency, and scalability. * Drive a culture of quality and compliance throughout the organization. ## Related Videos - [Beyond Dashboards: Fixing Text-to-SQL with Semantic RAG](https://www.wearedevelopers.com/videos/2036-beyond-dashboards-fixing-text-to-sql-with-semantic-rag) - [ZEISS & Microsoft - Building the Next Generation Medical Ecosystem in the Cloud](https://www.wearedevelopers.com/videos/424-zeiss-microsoft-building-the-next-generation-medical-ecosystem-in-the-cloud) - [REST, GraphQL, gRPC, and more: A comparison of modern API styles](https://www.wearedevelopers.com/videos/100247-rest-graphql-grpc-and-more-a-comparison-of-modern-api-styles) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Data Analytics with Microsoft Fabric: End-to-End Use Case with Data Agents](https://www.wearedevelopers.com/videos/1547-data-analytics-with-microsoft-fabric-end-to-end-use-case-with-data-agents) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Events like RSAC Get You CISOs. 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