Quality Manager - Medical Device Startup (Class II)

WearLinq is a growing medical device startup commercializing an FDA Class II device. We are seeking a proactive, hands-on Quality Manager to build, lead, and continuously improve our Quality Management System (QMS).

Requirements

• Maintain and improve a right-sized QMS tailored to a startup environment while ensuring compliance with FDA requirements.
• Manage document control, change control, training records, equipment calibration, and supplier quality.
• Prepare for and lead FDA and ISO audits once the company moves toward commercialization.
• Partner closely with R&D to embed quality into design control activities—design reviews, verification and validation planning, risk management, and design history file maintenance.
• Develop supplier qualification and monitoring processes appropriate for startup scale.
• Support process validation and production readiness activities with manufacturing partners.
• Lead root cause analysis, corrective/preventive actions, and trending.
• Maintain the risk management file per ISO 14971 throughout the product lifecycle.
• Contribute to complaint handling, vigilance, and post-market surveillance systems as commercial activities begin.
• Help establish systems for field actions and product improvements.
• Serve as the company’s primary quality lead and FDA liaison.
• Provide training and guidance to cross-functional teams on quality principles.
• Promote a culture of compliance, ownership, and continuous improvement.

Benefits

• Competitive startup compensation (salary + potential equity)
• Health, dental, and vision insurance
• Remote work option
• Professional growth opportunities as the company scales