Aegis Ventures

Senior QA/RA Specialist

Aegis Ventures

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $85,000 - $115,000 per year

Job Level

Senior

About the role

  • Support regulatory strategy and submission timelines for US market
  • Support management of medical device listing, establishment registration, and labeling compliance
  • Own quality oversight of supplier relationships for US market
  • Conduct supplier audits (remote and on-site) and manage audit findings to closure
  • Lead CAPA investigations and effectiveness verification
  • Manage incoming inspection criteria and supplier performance metrics
  • Coordinate design transfer and manufacturing scale-up activities
  • Maintain design control documentation (DHF) for hardware products
  • Handle complaint investigations and MDR reporting
  • Support document control and training record maintenance
  • Partner with Engineering on design verification/validation protocols
  • Work with Operations on manufacturing quality requirements
  • Coordinate with Director of QA/RA on global compliance strategy

Requirements

  • 7+ years of medical device quality assurance and regulatory affairs experience
  • Demonstrated experience supporting FDA 510(k) submissions
  • Proven track record managing contract manufacturer relationships and supplier quality
  • Experience conducting supplier audits and managing complex CAPA investigations
  • Hands-on experience with design controls and DHF maintenance for Class II devices
  • Expert knowledge of FDA regulations (21 CFR Part 820, Part 11, 510(k) pathway)
  • Strong understanding of ISO 13485 quality management system requirements
  • Proficiency in risk management per ISO 14971
  • Working knowledge of design control requirements and V&V best practices
  • Experience with complaint handling and MDR reporting
  • Experience with hardware medical devices (optical devices, cameras, or imaging systems) is preferred
  • Experience working with Asian contract manufacturers, particularly in China is preferred
  • Background in both software and hardware medical device environments is preferred
Benefits
  • Competitive compensation package, including a strong base salary, performance-based bonus, and the chance to earn upside.
  • Top-tier health, vision, dental, and commuter benefits.
  • Generous monthly health and wellness reimbursement.
  • Unparalleled exposure to new business building at the intersection of artificial intelligence and healthcare.
  • The opportunity to help solve difficult problems and collaborate with world-class experts from healthcare provider networks, academia, and industry.
  • A chance to work with a highly talented, close-knit team and world-leading mentors who can act as a support network and sounding board throughout your entrepreneurial journey.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical device quality assuranceregulatory affairsFDA 510(k) submissionssupplier auditsCAPA investigationsdesign controlsDHF maintenanceISO 13485risk managementcomplaint handling
Soft Skills
quality oversightmanagementcoordinationleadershipcommunication