Head of Product Quality

The role

You will build, scale, and maintain the Quality Management System (QMS) and serve as the primary quality authority for a medical device launch in Germany. You will oversee design controls, risk management, and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs.

What you will do

• Own, maintain, and continuously improve the QMS
• Define quality policy, objectives, and QMS scope
• Lead management review meetings and report quality metrics to the CEO
• Review and approve test plans and test reports for product development
• Own quality role in design controls and design history file content
• Own the risk management process aligned to ISO 14971
• Implement and run a formal document control system
• Establish supplier quality requirements and performance monitoring
• Own the CAPA process end to end
• Plan and execute the internal audit program

Required 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
• Experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products
• Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs
• Working knowledge of risk management per ISO 14971 or equivalent
• Ability to operate independently and make final quality decisions with minimal oversight
• Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience)

Nice to have

• Direct experience with EU MDR technical documentation and/or notified body audits
• ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification
• Experience standing up or administering an eQMS platform
• Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category
• Experience managing or mentoring a small quality team

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

About the company

PAX is a leading global cannabis brand on a mission to enhance people’s lives through pure products and unique experiences. The company has raised over $430MM in capital and is available in more than 40 countries.