Quality Assurance Coordinator

PhilipsOntario, CA
$26 - $41Onsite

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: Analyze quality data, trends, and performance metrics to identify improvement opportunities, drive corrective and preventive actions (CAPA), and support continuous improvement initiatives. 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. 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. 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. Ensure document integrity, traceability, and compliance through version control, DHF/DMR/DHR oversight, standardization reviews, archiving, retention management, and continuous process improvements. Manage supplier quality activities, including capability assessments, quality agreements, issue resolution, and collaboration on corrective actions to ensure product quality and compliance. 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. 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. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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

Benefits

  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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