7Seventy Recruiting · 14 hours ago
Quality Assurance Specialist - $41.00 - $55.00 per hour
United States
Full-time
Remote
Senior Level
$41/hr - $55/hr
7+ years exp7Seventy Recruiting is seeking an experienced Senior Quality Assurance / Regulatory Affairs Specialist to lead quality and regulatory operations for U.S.-marketed medical hardware products. The role is critical in ensuring FDA compliance, supplier quality oversight, and post-market activities while supporting commercial scale and entry into new markets.
Information Services
Responsibilities
Support regulatory strategy and submission timelines for the U.S. market
Manage medical device establishment registration, listing, and labeling compliance
Own quality oversight of supplier relationships for U.S.-marketed products
Conduct supplier audits (remote and on-site) and manage corrective actions to closure
Lead CAPA investigations and effectiveness verification activities
Define and manage incoming inspection criteria and supplier performance metrics
Coordinate design transfer activities and manufacturing scale-up initiatives
Maintain design history files (DHF) and design control documentation
Manage complaint investigations and support MDR reporting requirements
Support document control systems and training record maintenance
Partner with Engineering on design verification and validation protocols
Collaborate with Operations on manufacturing quality requirements
Support global compliance strategy in coordination with QA/RA leadership
Qualification
Required
7+ years of experience in medical device quality assurance and regulatory affairs
Hands-on experience supporting FDA 510(k) submissions
Proven experience managing contract manufacturers and supplier quality programs
Strong background conducting supplier audits and leading CAPA investigations
Experience maintaining DHF and design controls for Class II medical devices
Expert knowledge of FDA regulations, including 21 CFR Part 820, Part 11, and 510(k)
Strong understanding of ISO 13485 quality management systems
Experience with risk management processes aligned with ISO 14971
Working knowledge of design control requirements and V&V best practices
Experience with complaint handling and MDR reporting
Preferred
Exposure to hardware medical devices such as optical, imaging, or camera systems
Experience working with international contract manufacturers, including Asia
Background in both software and hardware medical device environments
Benefits
Competitive compensation with performance-based incentives
Comprehensive health, vision, and dental coverage
Monthly health and wellness reimbursement
Exposure to advanced healthcare and AI-driven technologies
Opportunity to work alongside experienced professionals across healthcare and technology
Company
7Seventy Recruiting
7Seventy Recruiting connects employers with qualified candidates through transparent, data-driven recruitment solutions.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase