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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in Quality Management Systems (QMS) within regulated environments, particularly in medical devices, with a strong focus on ISO 13485 and risk management per ISO 14971. Proven ability to lead quality initiatives, manage teams, and ensure compliance with regulatory standards.
Highest-signal resume keywords
ISO 13485 Quality Management SystemRisk Management per ISO 14971CAPA and Nonconformance ManagementEU MDR Technical DocumentationQuality Team Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality EngineeringDocument ControlVerification and Validation DocumentationInternal AuditsSupplier Quality ManagementTest Plan ReviewDesign ControlsRegulatory ComplianceQuality Metrics ReportingQuality System Development
Soft Skills
Independent Decision-MakingCoaching and TrainingCross-Functional Collaboration
Tools & Technologies
EQMS PlatformsMasterControlGreenlight GuruQualioETQ
Certifications & Qualifications
ASQ Certification (CQE, CQM/OE, CMQ/OE)ISO 13485 Lead Auditor Certification
Industry Keywords
Medical DeviceIVDCombination ProductRegulated HardwareConsumer Electronics
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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