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, 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.
• Provide oversight for Performance Qualification (PQ) activities associated with facilities, utilities, and infrastructure systems where applicable.
• 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.
• Ensure revalidation or documented impact assessment is performed following equipment, cleaning-process, facility, utility, software, or other validated-state changes.
• Lead or support computerized-system validation (CSV) for manufacturing systems and current or future laboratory systems, using a risk-based lifecycle approach consistent with intended use and applicable procedures.
• Provide Quality oversight for SAP and Greenlight Guru implementations, upgrades, interfaces, and regulated workflows, including requirements, risk assessments, testing, traceability, deviations, release, periodic review, and change control, as applicable.
• Support data-integrity validation and governance by ensuring regulated electronic records and systems are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available (ALCOA+), with appropriate access controls, audit trails, backup/recovery, and record retention.
• Provide Quality input to change controls, continued process verification, periodic review, and maintenance of the validated state throughout the system and equipment lifecycle.

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, and promote ownership, accountability, prevention, and continuous improvement.
• 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.

Work Environment

• Primarily indoor office/manufacturing environments; periodic travel may be required for supplier/CMO audits or other business needs.

Physical Demands

• Ability to stand, walk, sit, reach, use manual dexterity, and occasionally lift up to ten (10) pounds for an 8-hour workday.

The above description is intended to describe the general content, identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• Company-paid and voluntary life Insurance
• Company-paid disability insurance and benefits
• EAP
• 401(k) with company match
• Paid time off
• Paid family leave

EQUAL OPPORTUNITY EMPLOYER. It is our policy to abide by all federal, state and local laws prohibiting employment discrimination based solely on a person’s race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, physical disability, mental disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, sexual orientation, or any other protected status except where reasonable, bona fide occupational qualification exists.

Requirements

Bachelor’s degree required, preferably in Engineering, Quality, Life Sciences, or a related technical discipline.

Minimum 7 years of progressive Quality experience in medical device, pharmaceutical, or regulated life sciences; supplier quality experience strongly preferred.

Demonstrated experience with supplier qualification/auditing, supplier performance management, SCAR/CAPA, quality agreements, supplier change control, manufacturing investigations, nonconformances, root-cause analysis, and Quality oversight of validation/qualification activities in a regulated manufacturing environment.

Working knowledge of ISO 13485, FDA medical-device quality system requirements, MDSAP, GMP, ISO 14971 risk-management principles, validation/qualification lifecycle practices (IQ/OQ/PQ), cleaning validation, computerized-system validation, data integrity, statistical techniques, and SPC.

Proficient in Microsoft Office and organizationally leveraged quality/data applications.

Computerized Systems / SAP Preferred:

Hands-on experience with SAP ERP (e.g., SAP S/4HANA or SAP ECC), Greenlight Guru or a comparable eQMS, and computerized-system validation supporting quality and compliance processes.

- Experience working with SAP QM module or quality-related functionality (e.g., inspections, notifications, batch records)

- Proven ability to manage quality events (deviations, CAPAs, change controls) within SAP or SAP-integrated systems

- Strong understanding of data integrity, traceability, and audit trails within SAP environments

- Experience using SAP to support regulatory compliance, documentation, and audit readiness.

- Ability to review, validate, and ensure accuracy of regulated data maintained in SAP

Preferred Qualifications

ASQ CQE or CMQ/OE, Lean Six Sigma Green/Black Belt, or equivalent certification.

Experience with CMOs, vertically integrated medical-device manufacturing, eQMS/statistical software, and FDA/ISO 13485/MDSAP inspections or audits.