Quality Manager - Medical Device Startup; Class II

Position Summary

Wear Linq is hiring! We are a growing medical device startup commercializing an FDA Class II device. We’re seeking a proactive, hands‑on Quality Manager to build, lead, and continuously improve our Quality Management System (QMS). This role is ideal for a quality professional who thrives in a fast‑paced, early‑stage environment and wants to directly influence product development, regulatory readiness, and company culture.

You will be responsible for maintaining compliance with FDA 21 CFR Part 820 and ISO 14971
, while also supporting design control, supplier qualification, risk management, and post‑market processes.

Key Responsibilities

Quality System Development & Compliance

• 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.

Design & Development Support

• 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.
• Ensure design documentation aligns with regulatory expectations for Class II devices.

Manufacturing & Supplier Quality

• Develop supplier qualification and monitoring processes appropriate for startup scale.
• Support process validation and production readiness activities with manufacturing partners.
• Ensure inspection and release processes are defined and traceable.

CAPA, Nonconformance, and Risk Management

• Lead root cause analysis, corrective/preventive actions, and trending.
• Maintain the risk management file per ISO 14971 throughout the product lifecycle.

Post‑Market Readiness

• Contribute to complaint handling, vigilance, and post‑market surveillance systems as commercial activities begin.
• Help establish systems for field actions and product improvements.

Leadership & Culture

• 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.

Education & Experience

• Bachelor’s degree in engineering, life sciences, or related technical field (advanced degree preferred).
• 5+ years of experience in medical device quality assurance; startup or small‑company experience strongly preferred.
• Proven knowledge of FDA 21 CFR Part 820 and ISO 14971
  .
• Hands‑on experience with design control
  , risk management
  , and process validation for Class II devices.
• Experience leading or supporting FDA inspections or ISO audits
  .
• Familiarity with electronic QMS tools or willingness to implement one.

Skills & Attributes

• Entrepreneurial mindset with ability to build processes from the ground up.
• Excellent communication, organization, and problem‑solving skills.
• Comfortable balancing regulatory rigor with startup agility.
• Strong cross‑functional collaboration with R&D, operations, and regulatory teams.

Preferred Certifications

• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) a plus.
• ISO 13485 Lead Auditor certification a plus.

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