Sr. Quality Systems Engineer

Sirtex•Woburn, MA

7d•Hybrid

About The Position

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). This role operates independently, leads cross-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). Candidates must be local to the Boston, MA area and be able to adhere to our hybrid policy, which is currently 3 days/week in office and 2 days/week remote.

Requirements

Bachelor’s degree or higher in Engineering, Life Sciences, or a related technical field required
5+ years of experience in Quality Systems within the medical device, pharmaceutical, or biotech industries required
Proven experience administering and optimizing eQMS platforms (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 lead complex 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 to present to executive leadership and external auditors.
Detail-oriented with a strong compliance mindset and ability to ensure audit-ready documentation.

Nice To Haves

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.

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.
Serve as an internal authority on quality system requirements, providing guidance and interpretation to functional teams.
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.
Prepare and present quality data summaries and trend analyses for leadership and regulatory audiences.
Provide guidance for the end-to-end Corrective and Preventive Action (CAPA) and Nonconformance Report (NCR) processes, ensuring timely initiation, appropriate containment, robust root cause analysis, risk-based corrective actions, and documented verification of effectiveness.
Provide technical 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 through closure.
Support external regulatory inspections and notified body audits; coordinate audit logistics and manage response activities.
Responsible for providing quality system inputs and documentation and tracking outputs and action items for the Management 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.