Harmonic

Senior Director, Corporate Quality, Regulatory & Product Compliance

Harmonic

full-time

Posted on:

Location Type: Remote

Location: Texas • United States

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Salary

💰 $180,000 - $250,000 per year

Job Level

Senior

About the role

  • Own and evolve the global regulatory compliance strategy across all regions and product lines.
  • Leverage AI‑enabled regulatory intelligence tools to monitor regulatory changes and assess product impact.
  • Ensure compliance with UL, FCC, CE, RoHS, REACH, Prop 65, and other applicable standards.
  • Lead regulatory audits, certifications, and technical submissions using digitized compliance evidence systems.
  • Embed compliance requirements early in product architecture through close partnership with Engineering and Product teams.
  • Lead the corporate product safety program, including hazard analysis, FMEA, risk mitigation, and field actions.
  • Deploy data‑driven and AI‑assisted risk assessment methods to identify emerging safety issues.
  • Oversee investigations, RCA, and CAPA using advanced analytics across field, manufacturing, and reliability data.
  • Establish predictive safety metrics and dashboards for executive review.
  • Own enterprise ISO frameworks (ISO 9001, 14001, 45001, etc.).
  • Lead the transformation toward a digital, AI‑enabled QMS, including intelligent document control and continuous audit readiness.
  • Partner with global functions and manufacturing partners to ensure consistent QMS execution.
  • Own and govern the enterprise PLCM framework and stage‑gate process.
  • Implement AI‑driven launch readiness and risk scoring across NPI programs.
  • Provide executive visibility through integrated dashboards, predictive KPIs, and automated gate reviews.
  • Champion a quality‑first, data‑driven, and AI‑augmented culture across Engineering, Operations, Supply Chain, and Service.
  • Drive KPI governance using advanced analytics and trend‑based insights.
  • Influence senior leaders through clear, evidence‑based recommendations.

Requirements

  • 10 + years of experience in Quality, Regulatory, Product Safety, PLCM, or NPI in a hardware or regulated industry.
  • Proven experience scaling global quality and compliance programs.
  • Strong understanding of digital QMS, analytics, and AI applications in quality and operations.
  • Experience engaging engineering‑led organizations and executive leadership.
  • Experience managing contract manufacturers globally.
  • Advanced degree in Engineering, Quality, Operations, or Regulatory Affairs (preferred).
  • Experience implementing AI, automation, or advanced analytics in quality, compliance, or operations (preferred).
  • Lean, Six Sigma, DFx, or reliability engineering expertise (preferred).
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
  • Bonuses
  • Equity
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancerisk assessmenthazard analysisFMEACAPAadvanced analyticsdigital QMSAI applicationsLeanSix Sigma
Soft Skills
leadershipcommunicationinfluencecollaborationstrategic thinkingproblem-solvingdata-driven decision makingexecutive visibilitypartnershipgovernance
Certifications
ISO 9001ISO 14001ISO 45001advanced degree in Engineeringadvanced degree in Qualityadvanced degree in Operationsadvanced degree in Regulatory Affairs