Principal Device Quality Engineer

Role overview Serve as the global process owner for Corrective and Preventive Action (CAPA) and Non-Conformance (NC) subsystems at a medical technology company advancing the diagnosis and management of coronary artery disease. This Principal Quality Engineer role is a strategic, high-visibility position responsible for leading complex investigations, mentoring cross-functional teams, and continuously improving the QMS against FDA, ISO, and EU MDR expectations.

Responsibilities - Act as global process owner for the CAPA subsystem, ensuring records and actions are robust, effective, and compliant. - Monitor CAPA and NC health through KPIs and quality dashboards, communicating needed measures to CAPA owners and leadership. - Lead the CAPA Review Board, ensuring strong problem definition, investigation quality, and effectiveness checks. - Deliver training on the CAPA and NC subsystem and mentor cross-functional owners in R&D, manufacturing, and supplier quality on root cause analysis and audit-ready documentation. - Lead complex, high-risk investigations using structured root cause analysis tools, and partner with QE to keep the Risk Management File (ISO 14971) current as new failure modes emerge. - Serve as SME for CAPA and NC during internal and external audits (FDA, Notified Body, MDSAP) and conduct internal mock audits to surface gaps ahead of inspections.

Requirements - Bachelor's degree in Biomedical, Mechanical, or Industrial Engineering, or a related life science discipline; Master's or advanced certification (e.g., ASQ CQE, CQA, Six Sigma Black Belt) preferred. - 8+ years of Quality Engineering or QMS experience in Class II/III medical devices, with deep CAPA expertise. - Demonstrated experience interacting with regulators (FDA, TÜV, BSI, etc.) during inspections. - Working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR. - Proficiency with statistical and visualization tools (e.g., Tableau, Minitab) for trending and effectiveness verification. - Proven ability to drive quality outcomes across cross-functional teams without direct authority, plus strong technical writing skills for audit-facing investigation narratives.

Benefits and work setup - Base salary range of approximately $150,858–$155,000, plus cash bonus and equity. - Travel up to 15%. - Equal opportunity employer with reasonable accommodations available through the application and interview process.