Quality Assurance Coordinator

Philips•Ontario, CA

12h•Onsite

About The Position

As a Quality Assurance Coordinator, you will be responsible for maintaining daily management boards, conducting quality notification processes, and ensuring efficient communication and resolution of quality concerns, working under limited supervision. You will handle delivery hold activities, coordinate daily tasks, and track departmental metrics to ensure adherence to quality standards and regulatory requirements. You will contribute to the preparation of nonconforming material documentation for failed inspections or final release activities, and interact closely with stakeholders to resolve discrepancies and deviations, ensuring prompt and accurate documentation of quality issues. Your role involves analyzing quality data, trends, and performance metrics to identify improvement opportunities, drive corrective and preventive actions (CAPA), and support continuous improvement initiatives. You will lead investigations of quality issues and nonconformances, performing root cause analysis and partnering with cross-functional teams, suppliers, and external stakeholders to implement sustainable solutions. You will support and maintain quality management systems (QMS/eQMS), ensuring compliance with regulatory requirements, company policies, and industry best practices through accurate documentation and records management. Additionally, you will serve as the subject matter expert (SME) and business process owner for document control processes and systems, overseeing document lifecycle management, change control (CN/ECN), BOMs, deviations, QMS records, and related SAP/PowerCerv activities. You will ensure document integrity, traceability, and compliance through version control, DHF/DMR/DHR oversight, standardization reviews, archiving, retention management, and continuous process improvements. You will manage supplier quality activities, including capability assessments, quality agreements, issue resolution, and collaboration on corrective actions to ensure product quality and compliance. You will also support audits, inspections, and audit readiness efforts by serving as a key quality contact, providing documentation and evidence of compliance, and addressing quality-related inquiries. Finally, you will administer training and compliance activities, including LMS management, training records, KPI tracking, user support, and ongoing application of quality and business process expertise to achieve organizational objectives.

Requirements

High School Diploma or GED
2+ years of experience in Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination, or Warehouse Operations
Basic knowledge in Microsoft Excel, Word, PowerPoint, and Outlook

Responsibilities

Maintaining daily management boards
Conducting quality notification processes
Ensuring efficient communication and resolution of quality concerns
Handling delivery hold activities
Coordinating daily tasks
Tracking departmental metrics
Contributing to the preparation of nonconforming material documentation
Interacting closely with stakeholders to resolve discrepancies and deviations
Analyzing quality data, trends, and performance metrics
Leading investigations of quality issues and nonconformances
Performing root cause analysis
Partnering with cross-functional teams, suppliers, and external stakeholders
Supporting and maintaining quality management systems (QMS/eQMS)
Serving as the subject matter expert (SME) and business process owner for document control processes and systems
Overseeing document lifecycle management, change control (CN/ECN), BOMs, deviations, QMS records, and related SAP/PowerCerv activities
Ensuring document integrity, traceability, and compliance
Managing supplier quality activities
Supporting audits, inspections, and audit readiness efforts
Administering training and compliance activities