Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA
Core
Lead global audits and quality oversight for Third-Party Logistics (3PL) providers, distribution hubs, and service suppliers in the medical device supply chain.
Role type
Staff Supplier Quality Engineer (Lead Auditor)
Builds
Global 3PL quality management programs, audit frameworks, and regulatory compliance for medical device distribution.
Domain
Medical Devices / Regulatory Quality / Supply Chain Logistics
Required skills
ISO 13485 Lead Auditor, 21 CFR Part 820, EU MDR, Good Distribution Practice (GDP), QMS platforms (Trackwise, SAP, Agile), Risk Management (ISO 14971), CAPA management, SCAR management
Preferred skills
Auditing temperature-controlled distribution, auditing service suppliers (sterilization, calibration, labs), mentoring junior staff
Technologies
Trackwise, SAP, Agile
Responsibilities
Design and maintain global 3PL quality management programs; Lead risk-based audits of 3PLs and service suppliers; Manage SCARs and CAPAs; Serve as SME for regulatory inspections; Drive process improvements in QMS software.
Seniority
Staff, strategic execution & mentorship