Quality Systems Coordinator

Quality Systems Coordinator

Support the GCX Healthcare Solutions Quality Management System (QMS) through coordination, documentation, and system/data support. This role helps keep core quality processes (CAPA, complaints, audits, change control, document control) organized and on track, while maintaining accurate data in ERP/QMS tools and turning that data into clear, visual dashboards. The Quality Systems Coordinator works closely with the Quality Systems Manager and Specialist to ensure the QMS is effectively maintained, easy for users to navigate, and continuously improving.

• QMS & Document Control:
  Support CAPA, Change Control, Complaint Management, Internal Audits, and Document Control.
• Maintain procedures, forms, and records; route documents for review/approval and manage controlled copies.
• ERP / QMS System Support:
  Maintain quality-related data in IFS, Assent Compliance, and QMS/document control tools.
• Assist users with workflow questions and basic troubleshooting.
• Help improve data accuracy and simple workflow enhancements related to quality.
• Metrics & Reporting:
  Update quality dashboards in Power BI and/or Excel (CAPA status, complaint trends, audit findings, training status). Prepare routine quality reports and visuals for Management Review and operational meetings.
• Audit, CAPA & Complaint Support:
  Coordinate internal/external audits and gather required documentation. Log, track, and follow up on CAPAs, complaints, and audit findings to support timely closure.
• General Support & Quality Requests:
  Maintain training records and matrices for QMS-related procedures. Receive, log, and process quality requests from internal teams and customers (including preparation and issuance of Declarations of Conformity and other quality-related customer documents).
• Assist with cross‑functional quality projects and communications as needed.

• Bachelor’s degree in a technical, science, business, or related field preferred; or associate degree plus relevant experience.
• 1–3 years in quality, ERP/QMS support, or a documented/regulated environment preferred.
• Experience with SharePoint, ERP systems (IFS or similar), and/or compliance platforms (Assent or similar) is a plus.
• Strong Excel skills; experience with Power BI or other dashboard tools preferred.
• Basic understanding of quality concepts; exposure to ISO 13485 / FDA QSR or other regulated environments is a plus.
• Detail‑oriented, organized, comfortable with data and multiple systems, and able to communicate clearly in writing and verbally.
• Knowledge of regulatory compliance topics (RoHS, REACH, Conflict Minerals, etc.).
• Effective communication and cross‑functional collaboration skills.

• Seniority level: Entry level
• Employment type: Full‑time
• Job function: Quality Assurance
• Industries: Hospitals and Health Care

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