Global Technical Complaints Manager – Transformation

Novocure Inc.

Portsmouth (NH)

Hybrid

USD 110,000 - 143,000

Full time

14 days+

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Job summary

Novocure Inc. in Portsmouth, NH is seeking a Manager, Technical Complaints to lead a global team and own the end-to-end complaint handling process.

This hybrid, full-time role partners with Quality, Regulatory Affairs, IT and Manufacturing to migrate from SAP to Veeva Vault Quality and drive data-driven decisions in a regulated medical device environment. You will influence stakeholders, transform processes, and support FDA inspections while ensuring inspection readiness and CAPA initiatives

Qualifications

  • Bachelor's degree in Engineering, Life Sciences or related field.
  • 5+ years of medical device quality experience with significant complaint handling responsibility.
  • 3+ years of people leadership in a global environment.
  • Hands-on Veeva Vault Quality Complaint Management experience.
  • Experience supporting FDA inspections and international audits.
  • Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, CAPA and post-market surveillance.
  • Strong analytical, communication and stakeholder management skills.

Responsibilities

  • Lead and develop a global team of Technical Complaint Specialists.
  • Own the end-to-end complaint handling process from intake through closure.
  • Lead the complaint handling transformation from SAP to Veeva Vault Quality.
  • Partner with IT and Quality Systems to define business requirements, workflows and system configuration.
  • Drive complaint trending, KPIs, executive dashboards and management reviews.
  • Identify quality signals and partner on CAPA and continuous improvement initiatives.
  • Support FDA inspections, notified body audits and global regulatory inspections.
  • Collaborate across Medical Safety, Regulatory Affairs, Engineering, Manufacturing, Patient Experience and Global Technical Services.
  • Champion standardized global complaint handling processes and inspection readiness.

Skills

Medical device quality
Complaint handling
Leadership
Regulatory knowledge

Education

Bachelor's degree

Tools

Veeva Vault Quality
SAP

Job description

Novocure Inc. in Portsmouth, NH is seeking a Manager, Technical Complaints to lead a global team and own the end-to-end complaint handling process.

This hybrid, full-time role partners with Quality, Regulatory Affairs, IT and Manufacturing to migrate from SAP to Veeva Vault Quality and drive data-driven decisions in a regulated medical device environment. You will influence stakeholders, transform processes, and support FDA inspections while ensuring inspection readiness and CAPA initiatives

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