Principal Quality Engineer – CAPA
HeartFlow, Inc
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $150,858 - $155,000 per year
Job Level
Lead
Tech Stack
Tableau
About the role
- Own the CAPA system and lead as the Subject Matter Expert (SME).
- Monitor the health of the CAPA and NC subsystem through development and analysis of Key Performance Indicators (KPIs).
- Facilitate and lead the Corrective and Preventive Action (CAPA) Review Board.
- Deliver training on CAPA and NC subsystem best practices.
- Lead complex, high-risk investigations using RCA tools.
- Act as the SME for CAPA and NC during internal and external audits.
Requirements
- 8+ years of Quality Engineering or QMS related experience in Medical Devices (Class II/III) with CAPA expertise.
- Bachelor's degree in Engineering (Biomedical, Mechanical, Industrial) or a related Life Science discipline.
- Demonstrated experience interacting with regulatory bodies (FDA, TUV, BSI, etc.) during inspections.
- Deep working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and EU MDR.
- Proficiency in tools (e.g., Tableau, Minitab) for trending data and verifying effectiveness checks.
Benefits
- Health insurance
- 401(k) plan
- Flexible work arrangements
- Paid time off
- Stock options
- Bonuses
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CAPA expertiseKey Performance Indicators (KPIs)Root Cause Analysis (RCA)Quality EngineeringQMSRisk Management21 CFR Part 820ISO 13485ISO 14971EU MDR
Soft skills
leadershipfacilitationtrainingcommunicationinterpersonal skills