Head of Product Quality

PAX Labs

3d•$175,000 - $265,000•Onsite

About The Position

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.

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, including having built or substantially matured a QMS from the ground up.
Demonstrated 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.
Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders.
Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience).

Nice To Haves

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 (e.g., MasterControl, Greenlight Guru, Qualio, ETQ).
Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line.
Experience managing or mentoring a small quality team.

Responsibilities

Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status.
Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve.
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 (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company.
Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound.
Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness.
Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end.
Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence.
Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software.
Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes.
Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms.
Own records retention and traceability — device history records, inspection records, training records, and audit trails — so any product or decision can be reconstructed on demand.
Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes.
Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers.
Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers.
Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling.
Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings.
Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions.
Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting.
Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure.
Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers).
Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements.
Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time.
Act as a direct, independent voice on quality and risk in cross-functional and executive discussions — comfortable saying no to a launch date when the evidence doesn't support it.
Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance.