Quality Operations Manager

Urgo Medical North America LLC•Fort Worth, TX

About The Position

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. The role owns risk-based supplier quality programs, supplier qualification and audits, supplier performance monitoring and improvement, quality agreements, supplier corrective actions, and oversight of supplier changes and validation activities. It also leads or oversees manufacturing investigations and CAPAs, and partners across functions to improve product quality, yield, process capability, and right-first-time performance. The manager establishes process-monitoring strategies and quality dashboards, applies Lean, Six Sigma, statistical methods, and structured problem solving, and provides Quality leadership for the Validation Master Plan and qualification and validation of facilities, utilities, equipment, cleaning processes, laboratory systems, and computerized systems. The role supports data-integrity governance and the validated state, including oversight of SAP and Greenlight Guru implementations and regulated workflows. The position ensures assigned quality processes comply with the QMS, ISO 13485, applicable FDA Quality Management System Regulation requirements, MDSAP, and internal procedures; supports audits and responses; and serves as a Quality Operations partner across UMNA. It may lead and develop assigned Quality Operations personnel, as applicable. The work is primarily in indoor office and manufacturing environments, with periodic travel potentially required for supplier or CMO audits and other business needs.

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 and 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.
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 and 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.

Nice To Haves

Hands-on experience with SAP ERP, such as SAP S/4HANA or SAP ECC, Greenlight Guru or a comparable eQMS, and computerized-system validation supporting quality and compliance processes.
Experience working with the SAP QM module or quality-related functionality, such as inspections, notifications, and batch records.
Ability to manage deviations, CAPAs, and 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.
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.

Responsibilities

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, internal and external supplier audit activities, audit follow-up, periodic requalification, and maintenance of the Approved Supplier List.
Establish supplier scorecards and performance reviews using quality metrics and risk indicators, and drive supplier improvement plans when performance is unacceptable.
Lead Supplier Corrective Action Requests and supplier nonconformance management, including containment, root-cause analysis, corrective action, product impact assessment, trending, and effectiveness verification.
Develop and maintain Quality Agreements with critical suppliers and CMOs.
Provide Quality oversight of supplier changes, manufacturing transfers, equipment and process moves, new supplier onboarding, and changes to materials, processes, facilities, test methods, specifications, and sub-suppliers; ensure appropriate change control, validation, and regulatory impact assessment.
Support supplier and CMO qualification and validation activities, review applicable validation documentation, and maintain supplier quality records.
Lead or oversee manufacturing deviations, nonconformances, process excursions, and product-quality investigations; ensure containment, product impact assessment, disposition support, and sustainable corrective action.
Manage CAPAs 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.
Establish SPC and process-monitoring strategies for critical processes and quality characteristics, including indicators, control limits, alert/action criteria, and escalation pathways.
Analyze and trend quality data to identify process drift, recurring defects, supplier and manufacturing risks, and preventive improvement opportunities; develop quality dashboards for leadership.
Apply Lean, Six Sigma, statistical methods, and structured problem solving to drive operational and quality-system improvements.
Own or provide Quality leadership for the site Validation Master Plan and its 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, environmental-monitoring systems, building-monitoring systems, pest-control systems, and critical utilities.
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 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 applicable Performance Qualification activities associated with facilities, utilities, and infrastructure systems.
Lead Quality oversight of cleaning validation for equipment trains and cleaning equipment, including studies, protocols, reports, and scientifically justified acceptance criteria.
Ensure revalidation or documented impact assessment is performed following changes to equipment, cleaning processes, facilities, utilities, software, or other validated-state elements.
Lead or support risk-based computerized-system validation for manufacturing systems and current or future laboratory systems.
Provide Quality oversight for SAP and Greenlight Guru implementations, upgrades, interfaces, and regulated workflows, as applicable.
Support data-integrity validation and governance for regulated electronic records and systems, including 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 system and equipment lifecycles.
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 and 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.