The Quality Systems Operations Manager leads the effective operation, governance, and continuous improvement of Quality Management System (QMS) processes, with a primary focus on CAPA and nonconformance management, audit and compliance, quality performance management, risk-based quality practices, and continuous improvement.
The base pay range for this position is: $133,740 - $183,887
- Lead, coach, and develop the Quality Systems team at the site, establishing clear objectives, priorities, responsibilities, and performance expectations while ensuring appropriate capabilities and resources are in place.
- Lead the governance, maintenance, and continuous improvement of assigned Quality Management System processes, establishing clear process ownership, accountability, performance expectations, and escalation mechanisms.
- Provide operational leadership and oversight for CAPA and nonconformance management, ensuring effective investigation, root cause analysis, corrective and preventive action, effectiveness verification, timely closure, and escalation of significant or systemic issues.
- Lead internal and external audit readiness and regulatory inspection support, ensuring effective preparation, organizational alignment, response development, remediation, and timely closure of findings.
- Ensure assigned QMS processes comply with applicable requirements, including ISO 13485:2016, ISO 14971:2019 Risk Management for Medical Devices, FDA Quality Management System Regulation (QMSR), and other applicable standards and regulations.
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