Sr. Quality Systems Engineer

Job Description

Senior Quality Systems Engineer

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 role operates independently, leads cross‑functional quality initiatives, drives continuous improvement across quality systems processes, and serves as a key administrator and subject matter expert for the electronic QMS (eQMS).

Candidates must be located in the Boston, MA area and comply with a hybrid policy of 3 days per week in office and 2 days per week remote.

• Maintain and administer the Quality Management System in full conformance with regulatory standards, including 21 CFR Part 820, ISO 13485, MDSAP, EUMDR, and QMSR.
• 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 validation status is maintained; coordinate system updates and manage associated change control activities.
• Develop, maintain, and analyze quality system metrics and key performance indicators (KPI) to identify trends 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.
• Provide quality system inputs and documentation for Management Review, ensuring 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.

• 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, Master Control, ETQ, Track Wise), 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.

• 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 Quality Docs 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.,…