Head of Product Quality

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $175k - $265k / year

⏰ Full Time

🔴 Lead

✅ Product Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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PAX

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2007

🛒 Retail

Retail

PAX is a company that specializes in the design and sale of high-quality vapes and vaporizers. Their product lineup includes the PAX MINI, PAX Plus, and a variety of vape pens and pods, such as the ERA GO and ERA PRO. They also offer consumables like all-natural gummies crafted with real fruit and Delta-9 THC. PAX focuses on delivering consistent quality and memorable experiences, all while showing a genuine passion for plant-based products. They offer a range of accessories and limited edition items, and provide personalization options to enhance the customer experience.

📋 Description

• Build, scale, and maintain PAX’s Quality Management System (QMS) • Serve as the primary quality authority for PAX’s medical device launch in Germany • Bridge ISO 13485 and ISO 9001 standards for consumer and medical-market hardware • Report quality metrics, risks, and system performance to the CEO and executive team • Review and approve test plans and test reports for new product development and sustaining engineering changes • Own design controls, verification and validation planning, design reviews, and design history file content • Make independent go/no-go quality calls on design transfer and product release • Own the ISO 14971-aligned risk management process • Implement and administer document control, records retention, traceability, and eQMS tooling • Establish supplier quality requirements, inspections, audits, scorecards, and corrective actions • Own CAPA, nonconformance, complaint handling, and post-market surveillance processes • Plan and execute internal audits and serve as quality contact for external audits and regulatory inspections • Partner with Regulatory Affairs on EU MDR technical documentation and quality-system evidence • Build the quality function roadmap, headcount plan, and budget; hire and develop quality staff • Train and coach Engineering, Operations, and Sales teams on quality-system expectations

🎯 Requirements

• 10+ years of progressive quality engineering / quality systems experience in 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 • Experience building or substantially maturing a QMS from the ground up • Experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products • 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, including release holds, with minimal oversight • Bachelor's degree in engineering, a 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 standing up or administering an eQMS platform such as MasterControl, Greenlight Guru, Qualio, or ETQ • 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 in the Mission District of San Francisco • Employee Assistance Program including access to online legal support • Reasonable accommodation for individuals with disabilities