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Senior QA/RA Specialist

57 minutes ago
United States
Full-time
Senior
Manual QA Tester
Quality Assurance and Testing
Machine Learning
Apply Now
Aegis Ventures

Aegis Ventures

Aegis Ventures operates as a next generation venture studio that collaborates with entrepreneurs and industry leaders to create, launch, and expand innovative companies aimed at addressing significant societal challenges.

Professional Services
51-250
Founded 2020
View All Jobs 5

Description

  • Own quality and regulatory operations for the US hardware product line and support the broader product portfolio.
  • Support regulatory strategy and submission timelines for the US market.
  • Manage medical device listing, establishment registration, and labeling compliance.
  • Oversee supplier quality, including supplier relationships, audits, and closure of audit findings.
  • 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, including the DHF, for hardware products.
  • Handle complaint investigations and MDR reporting.
  • Support document control, training record maintenance, and cross-functional work with Engineering, Operations, and QA/RA leadership.

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, including 21 CFR Part 820, Part 11, and the 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 verification/validation best practices.
  • Experience with complaint handling and MDR reporting.
  • Experience with hardware medical devices such as 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.
  • Ability to work independently with minimal oversight and strong decision-making capability.
  • Excellent written and verbal communication skills for regulatory submissions and audits.
  • Strong project management skills with the ability to manage multiple priorities.
  • Analytical mindset for root cause analysis and problem-solving.
  • Collaborative approach to working with engineering, operations, and international teams.

Benefits

  • Competitive compensation package with a strong base salary, performance-based bonus, and upside potential.
  • Top-tier health, vision, dental, and commuter benefits.
  • Generous monthly health and wellness reimbursement.
  • Fully remote position based in the United States.
  • Up to 30% travel for site visits, training activities, or company meetings.
  • Opportunity for unparalleled exposure to business building at the intersection of artificial intelligence and healthcare.
  • Chance to work with world-class experts across healthcare provider networks, academia, and industry.
  • Salary range of $85,000 to $115,000 base salary depending on experience and role alignment.

Interested in this position?

Apply directly on the company website

Apply Now

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