Quality Systems and Compliance Lead
$142,000–$213,000 year
On-siteBoston, Massachusetts, United States or Dallas, Texas, United States
Job Summary
Lead the ongoing vision and implementation of the Quality Management System (QMS) spanning consumer, research, and medical device quality, including AI/ML-enabled and generative AI products, in conformance with domestic and international GMP, GCP, GCLP, and GLP requirements. Drive strategic and tactical Quality Planning activities with cross-functional stakeholders to ensure quality frameworks are fit-for-purpose across medical device, research, and commercial programs. Develop oversight frameworks for AI/ML products involving model validation, monitoring, and algorithmic change protocols aligned with emerging regulatory guidance. Maintain ISO 13485:2016 certification and lead expansion to additional certifications like MDSAP. Analyze quality metrics to identify trends, drive continuous improvement, and implement corrective and preventive actions. Staff and develop the QA team while fostering a culture of organizational compliance through GxP training and quality awareness initiatives. Partner with engineering and product teams to embed quality practices into software development workflows using tools like Jira and GitHub.
Required Qualifications
- Bachelor's degree in a scientific, engineering, or related field
- 8+ years of experience in quality assurance or regulatory affairs within the medical device, digital health, or life sciences industry
- Demonstrated experience leading or managing a QMS in conformance with ISO 13485:2016 and FDA QMSR
- Hands-on experience with design and development
- Experience with CAPA
- Risk management processes per ISO 14971
- Medical device software lifecycle processes per IEC 62304
- Experience supporting or managing quality across SaMD and/or AI/ML-enabled products
- Working knowledge of applicable FDA guidance and international regulatory frameworks
- Proven ability to lead cross-functional quality initiatives
- Proven ability to manage and develop QA teams
- Proven ability to influence stakeholders across engineering, product, and clinical organizations
- Experience with Jira and GitHub (or equivalent tools) is a plus for supporting SaMD and AI/ML quality processes including change control, issue tracking, and Design and Development File management per ISO 13485:2016
Desired Qualifications
- Experience with MDSAP audit programs and/or leading successful ISO 13485 certification or surveillance audits
- Familiarity with emerging regulatory frameworks for AI/ML-based SaMD, including FDA's predetermined change control plan (PCCP) guidance and international harmonization efforts (e.g., IMDRF)
- Experience supporting quality across GCP and/or GCLP environments, including clinical research or laboratory-based programs
- Proficiency with Google Workspace and software development and quality tools such as Jira and GitHub for change control, nonconformance tracking, and design and development file management
- Advanced degree (MS, MPH, PhD) in a relevant scientific or engineering discipline
- A recognized quality certification such as ASQ CQE, CQA, or RAC
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