Senior Director, Corporate Quality, Regulatory & Product Compliance

🕒 vor 2 Monaten

🤠 Texas – Remote

info

💵 $180.000 - $250.000 / Jahr

⏰ Vollzeit

🟠 Senior

🚔 Compliance

🦅 H1B-Visum-Sponsor

info

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Harmonic

Harmonic

1001 - 5000 Mitarbeiter

📡 Telekommunikation

☁️ SaaS

🔧 Hardware

💰 €10.500.000 Venture Round - Omneon im 2004-04

Telecommunications • SaaS • Hardware

Harmonic ist ein globaler Anbieter von Breitband- und Videotechnologie für Dienstleister und Medienunternehmen. Es entwickelt Breitbandzugangsplattformen (cOS), verteilte Zugangsarchitekturgeräte (DAA) und Fiber/DOCSIS-Lösungen, um Multi-Gigabit-Netzwerke zu ermöglichen und liefert Netzwerk-Edge-Hardware (optische Knoten, OLTs, Transceiver) an Betreiber. Harmonic bietet auch cloud-native SaaS und Software für Medienverarbeitung, Live- und On-Demand-Streaming, Werbemonetarisierung (VOS360 Ad & Media) und Managed Services zur Vereinfachung von Abläufen und Beschleunigung von Implementierungen an.

Beschreibung

• 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.

🎯 Anforderungen

• 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).

🏖️ Vorteile

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development • Bonuses • Equity

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