Sirtex Medical Limited

Sirtex Medical Limited

Sr. Quality Systems Engineer

Woburn, MA, United States · Senior

Sponsorship not specified$94k-$119kDetected 21 days ago
Data VisualizationExcelAuditingLogisticsSystems EngineeringFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingInternal Audit

About the role

  • The Senior Quality Systems Engineer is responsible for maintaining, improving, and ensuring compliance of the Quality Management System (QMS) in alignment with applicable medical device regulations (e.g., FDA QMSR/21 CFR Part 820, ISO 13485, MDSAP).
  • The position also serves as a key administrator and subject matter expert for the electronic QMS (eQMS).

Responsibilities

  • Maintain and administer the Quality Management System in full conformance with applicable regulatory standards, including 21 CFR Part 820, ISO 13485 MDSAP, EUMDR, and QMSR.
  • Proactively identify systemic gaps, develop improvement initiatives, and drive implementation through cross-functional collaboration.
  • Administer and maintain the electronic Quality Management System (eQMS), including configuration, user management, workflow design, and ongoing optimization.
  • Ensure eQMS system validation status is maintained; coordinate system updates and manage associated change control activities.
  • Develop, maintain, and analyze quality system metrics and key performance indicators (KPIs) to identify trends, assess system performance, and support data-driven decision-making.
  • Support external regulatory inspections and notified body audits; coordinate audit logistics and manage response activities.
  • Lead cross-functional initiatives to enhance QMS effectiveness, efficiency, and scalability.

Requirements

  • Bachelor's degree or higher in Engineering, Life Sciences, or a related technical field required
  • Proven experience administering and optimizing eQMS platforms (e.g., Veeva Vault, MasterControl, ETQ, TrackWise), including workflow configuration and governance required.
  • Strong working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, MDSAP, and global regulatory requirements required.
  • Excellent written and verbal communication skills with the ability to present to executive leadership and external auditors.
  • Detail-oriented with a strong compliance mindset and ability to ensure audit-ready documentation.

Nice to have

  • Advanced degree (MS, MBA) in a technical or related field.
  • ASQ certification (e.g., CQE, CQA) or equivalent professional certification.
  • Direct experience with Veeva Vault QualityDocs or similar cloud-based eQMS platforms.
  • 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.
  • Actual compensation may vary depending on the confirmed job-related skills and experience.

Compensation

  • $94k-$119k

Benefits

  • Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Company info

  • An unwavering commitment to company values, employee safety and excellence in everything we do.

Equal opportunity

  • All your information will be kept confidential according to EEO guidelines.
  • Sirtex is An Equal Opportunity/Affirmative Action Employer.
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