Principal Device Quality Engineer

This is a fully remote position, open to applicants in California.

📋 Description

• Take ownership of the global CAPA subsystem and serve as the process owner and subject matter expert (SME) for Non-Conformance and CAPA processes.

• Conduct intricate investigations and act as the primary reviewer for CAPA.

• Track CAPA and NC key performance indicators (KPIs) and quality dashboards, communicating necessary actions to stakeholders and management.

• Lead the transition and integration of CAPA processes to align with changing regulatory priorities.

• Organize and facilitate CAPA Review Boards, focusing on problem identification, investigations, and effectiveness evaluations.

• Provide CAPA and NC training throughout the organization.

• Mentor R&D, Manufacturing, and Supplier Quality leaders on root cause analysis, investigations, effective solutions, and comprehensive documentation.

• Direct complex, high-risk investigations utilizing root cause analysis methodologies.

• Collaborate with the Quality Engineering team to connect NC/CAPA investigations with the ISO 14971 Risk Management File.

• Serve as the CAPA and NC SME during FDA, Notified Body, and MDSAP audits.

• Conduct internal mock audits of Quality Management System (QMS) subsystems.

• Lead cross-functional teams to promote systemic quality enhancements while ensuring compliance with FDA, ISO, and EU MDR standards.

⛳️ Requirements

• A Bachelor’s degree in Engineering (Biomedical, Mechanical, Industrial) or a related Life Science field.

• Over 8 years of experience in Quality Engineering or QMS related roles within the Medical Devices sector (Class II/III), with a focus on CAPA.

• Proven track record of interacting with regulatory agencies (FDA, TUV, BSI, etc.) during inspections.

• Extensive knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and EU MDR regulations.

• Skilled in using tools like Tableau and Minitab for data trending and effectiveness verification.

• Demonstrated ability to achieve results and uphold quality standards with cross-functional teams without direct reporting authority.

• Exceptional writing skills for producing clear, concise, and technically accurate investigation reports.

• Background in root cause analysis, CAPA, non-conformance, QMS, audits, and risk management.

• A Master’s degree or advanced certification (e.g., ASQ CQE, CQA, Six Sigma Black Belt) is preferred.

🏝️ Benefits

• Cash bonus.

• Equity.

• Travel up to 15%.