[Hiring] Head of Product Quality @PAX Labs

Role Description

As the Head of Product Quality, you will build, scale, and maintain PAX’s Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks.

Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion.

Responsibilities

• Quality Management System (QMS)
  • Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles.
  • Define the quality policy, quality objectives, and QMS scope.
  • Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team.
  • Determine which QMS elements apply to which product lines.
• Design & Development Quality (Test Plans, Test Reports, V&V)
  • Review and approve test plans and test reports for new product development.
  • Own quality's role in design controls.
  • Partner with Engineering from concept through launch.
  • Make independent go/no-go quality calls on design transfer and product release.
• Risk Management
  • Own the risk management process aligned to ISO 14971 principles.
  • Ensure risk files are living documents updated through the product lifecycle.
• Document & Records Control
  • Implement and run a formal document control system.
  • Own records retention and traceability.
  • Select, implement, and administer the document control / eQMS tooling.
• Supplier & Manufacturing Quality
  • Establish supplier quality requirements and ongoing performance monitoring.
  • Own incoming inspection, in-process, and outgoing quality control specifications.
  • Drive supplier corrective action for quality escapes.
• CAPA, Nonconformance & Complaint Handling
  • Own the CAPA process end to end.
  • Run the nonconformance process for in-process and incoming material issues.
  • Own product complaint handling and post-market surveillance data.
• Internal Audit & Regulatory Quality Support
  • Plan and execute the internal audit program against QMS procedures.
  • Serve as the primary quality point of contact for external audits and regulatory inspections.
  • Partner closely with Regulatory Affairs on EU MDR technical documentation.
• Leadership & Cross-Functional Partnership
  • Build the quality function's roadmap, headcount plan, and budget.
  • Act as a direct, independent voice on quality and risk in discussions.
  • Train and coach Engineering, Operations, and Sales teams on quality-system expectations.

Qualifications

• 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment.
• Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 quality management systems.
• Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation.
• Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs.
• Working knowledge of risk management per ISO 14971 or equivalent.
• Proven ability to operate independently and make final quality decisions.
• Bachelor's degree in engineering, a physical science, or a related technical field.

Benefits

• Competitive compensation, equity & bi-annual performance reviews.
• Fully funded comprehensive medical, dental, and vision coverage.
• 401K plan.
• Generous PTO policy.
• Paid Parental Leave.
• Monthly wellness reimbursement.
• Cell Phone reimbursement.
• Employee Purchase Program for discounted PAX devices.
• Weekly catered lunch, endless snacks and beverages.
• Dog Friendly HQ in the Mission District of San Francisco.
• Employee Assistance Program including access to online legal support.

Compensation

This role has a pay range between $175,000 - $265,000 and equity. The final salary offer will be determined based on a variety of factors including depth of experience, geographic location, and relevant education/training.