Overview
Staff Quality Assurance Engineer Jobs in Orange County, CA at Relief Cardiovascular
Title: Staff Quality Assurance Engineer
Company: Relief Cardiovascular
Location: Orange County, CA
About Relief Cardiovascular
Relief Cardiovascular is a pioneering medical device start up dedicated to transforming the management of heart failure. The company’s technology, the Relief System, is a transcatheter smart implant designed to monitor and modulate renal vein pressures to improve fluid management in heart failure patients.
Job Description
The Senior/Staff Quality Engineer, will serve as a critical quality partner across both research and development and early-stage manufacturing for the Relief Cardiovascular implant development team. This is a hybrid role designed for a fast-moving startup environment – you will support implant R&D activities alongside the implant lead while also driving immediate manufacturing quality priorities. You will own complaint handling and serve as the quality-side owner of vigilance reporting, partnering closely with Regulatory Affairs on reportability determinations and submissions. You will also be a key contributor to EU MDR Technical Documentation and FDA inspection readiness. This is a full-time, on-site position based at our headquarters in Irvine, CA.
Skills & Responsibilities
• Serve as the primary quality partner to the implant lead, supporting design and development activities across all implant subsystems.
• Own and maintain Design History Files (DHFs) and ensure all design control documentation is audit-ready per 21 CFR Part 820 and EU MDR Annex II.
• Own the quality inputs to EU MDR Technical Documentation (Annex II & III), including design and manufacturing information, general safety and performance requirements (GSPR), and benefit-risk analysis documentation.
• Support Clinical Evaluation Report (CER) Processes by providing quality and risk management documentation inputs required under EU MDR.
• Develop and execute design verification and validation (V&V) plans and reports in alignment with regulatory requirements.
• Provide quality support for animal studies and hemodynamic monitoring activities, ensuring proper documentation and traceability.
• Lead FDA inspection readiness efforts within the R&D function, maintaining a state of continuous audit preparedness.
• Supports vigilance reporting by owning the complaint investigation, root cause, and reportability assessment that feeds into regulatory submissions.
• Manage complaint handling for implant-related product complaints end-to-end, including intake, investigation, root cause analysis, regulatory reportability determination, and closure.
• Maintain complaint handling and vigilance SOPs, ensuring alignment with FDA and EU MDR requirements as the product advances through development and into clinical use.
• Conduct risk management activities per ISO 14971 in collaboration with cross-functional R&D teams.
• Ensure supplier qualification and compliance for all R&D-related vendors, components, and external testing laboratories.
• Drive nonconformance investigations, CAPAs, and change control processes related to design and development activities.
• Collaborate with Regulatory Affairs to support 510(k), PMA, or IDE submissions requiring quality documentation.
Preferred Skills & Hands-On Experience
• Hands-on experience with Class III implantable medical devices or other highly regulated safety-critical products.
• Direct experience with vigilance reporting under EU MDR (Article 87) and FDA MDR reporting (21 CFR Part 803).
• Deep knowledge of design controls per 21 CFR Part 820 and ISO 13485.
• Familiarity with implantable device standards including ISO 14708 and IEC 60601.
• Experience supporting or managing FDA inspections and notified body audits.
• Background in animal study quality support and Good Laboratory Practice (GLP) environments.
• Proficiency in risk management tools and FMEA methodologies.
• Experience with supplier qualification programs including supplier audits and approved supplier list (ASL) management.
Education & Work Experience
• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 5 years of experience in quality engineering within medical device research and development.
• ASQ Certified Quality Engineer (CQE) or equivalent certification is a plus.
Compensation & Benefits
Our salary ranges are determined based on role, level, and relevant industry factors. Compensation for this position will be based on an individual’s job-related knowledge, skills, experience, education, and certifications. We also assess internal equity and current market conditions when determining salaries.
• Base salary range: $115,000 to $165,000
• Equity participation
• Comprehensive benefits package (health, dental, vision, 401k, etc.)
At Relief Cardiovascular, you will be part of a mission-driven team pushing the boundaries of heart failure innovation. Join us in developing next-generation cardiovascular technology that has the potential to transform patient care.
