Sr. Quality Systems Engineer
$94,000–$119,000 year
HybridWoburn, Massachusetts, United States
Job Summary
Maintain and administer the Quality Management System in full conformance with FDA QMSR, ISO 13485, and MDSAP standards. Lead cross-functional quality initiatives by driving CAPA, nonconformance, and audit processes while serving as the subject matter expert for the electronic QMS. Develop quality metrics and KPIs to analyze trends and support data-driven decision-making for leadership and regulatory audiences. Coordinate internal and external regulatory inspections, manage system validation status, and ensure Management Review activities meet defined schedules. Operate independently to enhance QMS effectiveness and drive a culture of continuous improvement across the organization.
Required Qualifications
- Bachelor's degree or higher in Engineering, Life Sciences, or a related technical field
- 5+ years of experience in Quality Systems within the medical device, pharmaceutical, or biotech industries
- Proven experience administering and optimizing eQMS platforms (e.g., Veeva Vault, MasterControl, ETQ, TrackWise), including workflow configuration and governance
- 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
- 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
- Must be local the Boston, MA area
- Must be able to adhere to our hybrid policy, which is currently 3 days/week in office and 2 days/week remote
Desired 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 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
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