Quality Operations Manager

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.

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.
• Support supplier/CMO qualification and validation activities, including review of IQ/OQ/PQ, process/cleaning/test-method validation documentation, 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.
• Manage CAPAs arising from investigations, audits, supplier issues, and quality trends; monitor aging, overdue actions, effectiveness, recurrence, and significant risk escalation.
• Partner with Manufacturing, Engineering, Technical, and QC to prevent defects and improve product quality, yield, process capability, and right-first-time performance.

Process Improvement, SPC & Quality Performance

• Establish SPC and process-monitoring strategies for critical processes and quality characteristics, including meaningful indicators, control limits, alert/action criteria, and escalation pathways.
• Analyze and trend quality data to identify process drift, recurring defects, supplier/manufacturing risks, and preventive improvement opportunities; develop concise quality dashboards for leadership.
• Apply Lean, Six Sigma, statistical methods, and structured problem solving to drive operational and quality-system improvements.

Manufacturing Systems, Validation, Qualification & Change Control

• Own or provide Quality leadership for the site Validation Master Plan (VMP), ensuring a documented, risk-based lifecycle approach for manufacturing systems, facilities, utilities, equipment, cleaning processes, laboratory systems, and computerized systems.
• Provide Quality oversight for facility qualification and IQ/OQ activities, including cleanroom qualification and environmental-monitoring systems, building-monitoring systems, pest-control systems, and critical utilities such as purified water and compressed air.
• Establish equipment qualification and requalification strategies; review and approve risk assessments, protocols, reports, deviations, acceptance criteria, and changes supporting IQ/OQ/PQ and process performance qualification.
• Oversee qualification and ongoing compliance of Environmental Monitoring (EM) systems and associated monitoring programs.
• Provide Quality oversight of the equipment calibration program, including calibration status, out-of-tolerance assessments, preventive actions, and escalation of product-impact risks.
• Lead Quality oversight of cleaning validation for equipment trains and cleaning equipment, including residue studies, swab and rinse recovery studies, dirty and clean hold-time studies, qualification protocols/reports, and scientifically justified acceptance criteria.
• Lead or support computerized-system validation (CSV) for manufacturing systems and current or future laboratory systems, using a risk-based lifecycle approach.
• Provide Quality oversight for SAP and Greenlight Guru implementations, upgrades, interfaces, and regulated workflows.
• Support data-integrity validation and governance by ensuring regulated electronic records and systems meet ALCOA+ requirements with appropriate access controls, audit trails, backup/recovery, and record retention.

QMS, Audit Readiness & Cross-Functional Leadership

• Ensure assigned quality processes comply with the QMS, ISO 13485, applicable FDA Quality Management System Regulation requirements, MDSAP, and internal procedures.
• Support internal, supplier, notified body/MDSAP, and regulatory audits and ensure timely, effective responses to observations.
• Serve as a Quality Operations partner across UMNA; facilitate quality reviews, coach process owners on investigations, CAPA, supplier quality, risk management and SPC.
• Lead and develop assigned Quality Operations personnel, as applicable, with clear responsibilities and performance expectations.

Competencies

• Strong supplier-quality, investigation, CAPA, project-management, facilitation, and problem-solving skills.
• Strong analytical capability with practical application of quality tools, statistical methods, and SPC.
• Excellent written/verbal communication and ability to influence suppliers, cross-functional teams, and leadership.
• High degree of rigor, accountability, initiative, organization, and sound judgment; ability to manage multiple priorities.