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GCX · 2 weeks ago

Quality Systems Coordinator

El Paso, TX

Full-time

Onsite

Entry Level

1+ years exp

GCX is a company focused on healthcare solutions, and they are seeking a Quality Systems Coordinator to support their Quality Management System. The role involves coordinating quality processes, maintaining accurate data, and assisting with audits and quality requests.

Health Care

Senior Management

H1B Sponsor Likely

Responsibilities

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 (e.g., CAPA status, complaint trends, , audit findings, training status)

Prepare routine quality reports and visuals for Management Review and operational meetings

Audit, CAPA & Complaint Support

Help 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

Qualification

Quality Management System (QMS)ERP systems (IFS)Power BIISO 13485Regulatory compliance knowledgeSharePointExcelDetail-orientedEffective communicationCross-functional collaboration

Required

Detail-oriented, organized, comfortable with data and multiple systems, and able to communicate clearly in writing and verbally

Effective communication and cross-functional collaboration skills

Preferred

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

Knowledge of regulatory compliance topics (RoHS, REACH, Conflict Minerals, etc.)

Company

GCX

By dedicating ourselves specifically to the healthcare industry, we have been able to develop a unique understanding of the interaction between medical devices, users, and healthcare environments.

Founded in 1971

Petaluma, California, USA

201-500 employees

https://www.gcx.com/

H1B Sponsorship

GCX has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)