Head of Product Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, enhance, and uphold PAX’s Quality Management System (QMS)

• Act as the chief quality authority for PAX’s medical device launch in Germany

• Integrate ISO 13485 and ISO 9001 standards for both consumer and medical-market hardware

• Present quality metrics, risks, and system performance data to the CEO and executive team

• Evaluate and authorize test plans and reports for new product development and ongoing engineering modifications

• Manage design controls, verification and validation planning, design reviews, and design history file documentation

• Make autonomous go/no-go quality decisions regarding design transfers and product releases

• Oversee the ISO 14971-compliant risk management process

• Implement and manage document control, records retention, traceability, and eQMS tools

• Define supplier quality standards, including inspections, audits, scorecards, and corrective actions

• Manage CAPA, nonconformance, complaint resolution, and post-market surveillance processes

• Organize and conduct internal audits, serving as the quality contact for external audits and regulatory inspections

• Collaborate with Regulatory Affairs on EU MDR technical documentation and quality-system evidence

• Create the quality function roadmap, headcount strategy, and budget; recruit and develop quality personnel

• Educate and mentor Engineering, Operations, and Sales teams on quality system expectations

⛳️ Requirements

• Over 10 years of progressive experience in quality engineering/quality systems within a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware)

• Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems

• Proven experience in establishing or significantly enhancing a QMS from the ground up

• Expertise in reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products

• Experience in managing document control, CAPA, nonconformance, supplier quality, and internal audit programs

• Familiarity with risk management in accordance with ISO 14971 or equivalent

• Capability to operate autonomously and make final quality decisions, including release holds, with minimal supervision

• Bachelor’s degree in engineering, physical science, or a related technical field, or equivalent practical experience

• 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 in establishing or managing an eQMS platform such as MasterControl, Greenlight Guru, Qualio, or ETQ

• Background in cannabis, vaporization, consumer electronics, or a similarly fast-paced hardware sector

• Experience in 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 in the Mission District of San Francisco

• Employee Assistance Program including access to online legal support

• Reasonable accommodation for individuals with disabilities