Manager, Technical Complaints

Role: Lead global technical complaint handling for a medical device company specializing in oncology therapies, overseeing process transformation and compliance. Responsibilities: manage a worldwide team, own end-to-end complaint processes, lead system migration from SAP to Veeva Vault Quality, define workflows, drive data analytics, and support regulatory inspections. Requirements: Bachelor’s in Engineering, Life Sciences, or related; 5+ years in medical device quality, with substantial complaint handling experience; 3+ years of global leadership; hands-on Veeva Vault Quality experience; familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, CAPA, and post-market surveillance. Preferred: experience with Veeva Vault implementations, SAP-to-Veeva migration, Lean Six Sigma certification. HighValue: medical device, complaint management, GxP, FDA and international audits, process improvement, cross-functional stakeholder engagement, and digital system transformation. WorkSetup: hybrid Portsmouth, NH; occasional travel.