Reimagining entrepreneurship for the next generation of builders and problem-solvers

Senior QA/RA Specialist

QA EngineerQA EngineerFull TimeRemoteTeam 11-50Since 2020H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

55 days ago

Salary

$85K - $115K / year

7 yrs expEnglish

Job Description

• 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

Job 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.