Quality Operations Manager

Description: Are you looking for a company where your work has meaning, where you can make a real impact and learn every day? At Urgo Medical, we believe innovation can transform lives. Our mission: to help patients heal faster and better, through cutting-edge products and innovative digital services. Some wounds are severe, can become chronic, or may become infected, causing pain and isolation. By joining us, you will discover our mission, our foundation, our commitment to local industrialization, and the authentic energy of our teams. At Urgo Medical, we have many strengths: industrial, R&D, commercial... and all of them are essential. If you want to combine passion, impact, and innovation, this position is for you! JOB DESCRIPTION Job Title: Quality Operations Manager Classification: Exempt Position Type: Full-Time Reports to: Quality Director Job Location: Urgo Medical North America – Texas Version Date: August 8, 2026 Position Overview The Quality Operations Manager leads quality operations for Urgo Medical North America’s medical-device manufacturing systems, infrastructure, and external supplier network. The role has primary responsibility for Supplier Quality Assurance and supplier performance management and provides Quality leadership for computerized-system validation, facility and utility qualification, cleaning validation, equipment qualification and calibration, manufacturing investigations, CAPA, process improvement, SPC, and change control. The manager partners with Manufacturing, Engineering, Technical, Supply Chain, Regulatory Affairs, Quality Control, Information Technology, contract manufacturers, laboratories, and critical suppliers to proactively manage product-quality, patient-safety, data-integrity, and compliance risk. Duties and Responsibilities Supplier Quality Assurance & Supplier Management Own the risk-based Supplier Quality Assurance program for critical suppliers, contract manufacturers, laboratories, and external providers, including qualification, approval, monitoring, periodic re-evaluation, escalation, and disqualification. Lead supplier qualification, performance monitoring, and internal/external supplier audit activities, including quality assessments, risk classification, audit planning and execution, reporting, corrective-action follow-up, periodic requalification, and maintenance of the Approved Supplier List (ASL). Establish supplier scorecards and performance reviews using quality metrics, nonconformance trends, complaints, audit results, responsiveness, SCAR/CAPA performance, and other risk indicators; drive supplier improvement plans when performance is unacceptable. Lead Supplier Corrective Action Requests (SCARs) and supplier nonconformance management, ensuring effective containment, root-cause analysis, corrective action, product impact assessment, trending, and effectiveness verification. Develop and maintain Quality Agreements with critical suppliers and CMOs defining responsibilities for quality systems, change notification, investigations, validation, records, product release support, and escalation. Provide Quality oversight of supplier changes, manufacturing transfers, equipment/process moves, new supplier onboarding, and changes to materials, processes, facilities, test methods, specifications, and sub-suppliers; ensure appropriate UMNA change-control, validation, and regulatory impact assessment. Support supplier/CMO qualification and validation activities, including review of IQ/OQ/PQ, process/cleaning/test-method validation documentation, as applicable, and maintain supplier quality records. Manufacturing Quality, Investigations & CAPA Lead or oversee manufacturing deviations, nonconformances, process excursions, and product-quality investigations using appropriate root-cause and risk-analysis tools; ensure timely containment, product impact assessment, disposition support, and sustainable corrective action. Manage CAPAs arising from investigations, audits, s…

View the full posting and apply