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Head of Product Quality

10 hours, 9 minutes ago
United States
Full-time
Executive
QA Engineer
Quality Assurance and Testing
Apply Now
PAX

PAX

PAX is a leading company in the cannabis industry, offering exceptional vape, flower, and edible products for adults 21+. With a focus on consistent quality and memorable experiences, PAX delivers well-being through pure products and a genuine passion ...

Pharmaceuticals
201-500
Founded 2007
View All Jobs 5

Description

  • Own and continuously improve the QMS, applying ISO 13485 and ISO 9001 principles across consumer and medical hardware product lines.
  • Define quality policy, objectives, and QMS scope; lead management reviews and report quality performance, risks, and metrics to executive leadership.
  • Own design controls, including design inputs and outputs, V&V planning, design reviews, and Design History File completeness.
  • Review and approve test plans and reports, and make independent go/no-go decisions for design transfer and product release.
  • Lead ISO 14971-aligned risk management throughout the product lifecycle, including hazard analysis, risk controls, and residual-risk evaluation.
  • Implement document and records control processes and select and administer eQMS tooling.
  • Establish supplier quality requirements, inspection specifications, sampling plans, supplier monitoring, and corrective actions.
  • Own CAPA, nonconformance, complaint-handling, and post-market surveillance processes.
  • Plan and execute internal audits; serve as the primary quality contact for notified-body, certification-body, customer, and regulatory inspections.
  • Partner with Regulatory Affairs on EU MDR documentation, build the quality-function roadmap, and train cross-functional teams on quality-system requirements.

Requirements

  • 10+ years of progressive quality engineering or quality systems experience in regulated hardware, such as medical devices, IVDs, combination products, or similarly regulated consumer hardware.
  • Hands-on experience with ISO 13485 and/or 21 CFR 820/FDA QMSR, including building or substantially maturing a QMS.
  • Experience reviewing and approving test plans, test reports, and V&V documentation for physical or electromechanical hardware.
  • Experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs.
  • Working knowledge of ISO 14971 or equivalent risk-management practices.
  • Ability to independently make and communicate final quality decisions, including release holds, to executive stakeholders.
  • Bachelor’s degree in engineering, physical science, or a related technical field, or equivalent practical experience.
  • Experience with EU MDR technical documentation and/or notified-body audits (preferred).
  • ASQ certification or ISO 13485 Lead Auditor certification (preferred).
  • Experience administering eQMS platforms such as MasterControl, Greenlight Guru, Qualio, or ETQ; cannabis, vaporization, consumer-electronics, or small quality-team leadership experience is preferred.

Benefits

  • Salary range of $175,000–$265,000 plus equity and bi-annual performance reviews.
  • Fully funded medical, dental, and vision coverage.
  • 401(k) plan and generous PTO.
  • Paid parental leave and monthly wellness reimbursement.
  • Cell phone reimbursement and discounted PAX devices through the employee purchase program.
  • Employee Assistance Program with online legal support.
  • Weekly catered lunch, snacks, and beverages.
  • Dog-friendly San Francisco headquarters.

Interested in this position?

Apply directly on the company website

Apply Now

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