Global Technical Complaints Leader — Quality Transformation

Novocure Inc; Boston (MA); Hybrid; USD 110,000 - 143,000; Full time

Benefits offered by this job

Annual bonus

RSU grant

Job summary

Novocure Inc. seeks an experienced medical device quality leader to own the global technical complaint handling process. You’ll lead a global team, transform processes, and drive data‑driven decisions across QA, Regulatory, IT and Manufacturing in a highly regulated environment.

You will manage end-to-end complaint handling, support FDA and international audits, and spearhead the SAP to Veeva Vault Quality migration. This hybrid, Portsmouth, NH role offers growth and impact.

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

Complaint handling

Leadership

Regulatory knowledge

FDA inspections

CAPA

Quality systems

Lean Six Sigma

Migration SAP to Veeva

Data analysis

Veeva Vault Quality

Education

Bachelor's degree in Engineering, Life Sciences or related field

Tools

Veeva Vault

Job description

Novocure Inc. seeks an experienced medical device quality leader to own the global technical complaint handling process. You’ll lead a global team, transform processes, and drive data‑driven decisions across QA, Regulatory, IT and Manufacturing in a highly regulated environment.

You will manage end-to-end complaint handling, support FDA and international audits, and spearhead the SAP to Veeva Vault Quality migration. This hybrid, Portsmouth, NH role offers growth and impact.