Quality Systems Analyst

GCX Healthcare Solutions • El Paso, TX

14d

About The Position

Job Purpose: The Quality Systems Analyst supports the Quality Systems Manager by maintaining and improving quality system processes, ensuring data accuracy, and helping manage key compliance activities required under ISO 13485. This role focuses on system administration, reporting, document control support, compliance submissions, and basic audit preparation. Responsibilities Quality System Support (ISO 13485) Assist with key QMS processes including Document Control, CAPA, Complaints, Nonconforming Product, Internal Audits, and Training. Maintain accurate and complete quality system records. Help prepare documentation and data for internal and external audits. ERP / QMS System Support Maintain quality-related modules in the ERP and QMS systems. Support users with workflow questions and basic troubleshooting. Help improve system workflows and data accuracy as it pertains to quality. Metrics & Reporting Create and update quality metrics dashboards (CAPA status, complaint trends, NCR cycles, audit findings, etc.). Provide routine reporting for Management Review and operational meetings. Compliance Documentation Prepare Declarations of Conformity (DoCs). Complete customer compliance submissions (RoHS, REACH, Prop 65, Conflict Minerals). Manage routine activities related to the Assent Compliance Platform. Cross-Functional Support Support Quality Systems, Quality Engineering, Supplier Quality, and Operations with system data and reports. Provide user training for document control and ERP workflows as they pertain to quality. Continuous Improvement Identify simple process and system improvements. Assist in implementing updates to quality system tools or documentation. Job Qualifications/Requirements: Bachelor's degree in engineering, Information Systems, Business, Quality, or related field. 2–4 years of experience in quality systems, ERP administration, or regulatory compliance in a manufacturing or medical device environment. Experience with ISO 13485 QMS requirements strongly preferred. Proficiency in ERP systems (SAP, Epicor, Oracle, or equivalent) and QMS tools. Strong data analysis and reporting skills (Excel, Power BI, Tableau preferred). Knowledge of regulatory compliance topics (RoHS, REACH, Conflict Minerals, etc.). Strong attention to detail, organizational skills, and ability to manage multiple priorities. Effective communication and cross-functional collaboration skills. Compensation and Benefits Competitive salary; Generous bonus program tied to performance; Outstanding benefits package, including Medical/Prescription, FSA, H.S.A., Dental, Vision, STD/LTD and Life/AD&D insurance; 401k and Financial Services; and Paid Vacation. Why Join GCX? This role places you at the center of driving operational success and customer trust in a fast-growing medical device manufacturing organization. You'll contribute directly to ensuring patient-ready products are delivered on time while fostering trusted OEM partnerships. Join a company where precision, service, and impact truly matter.

Requirements

• Bachelor's degree in engineering, Information Systems, Business, Quality, or related field.
• 2–4 years of experience in quality systems, ERP administration, or regulatory compliance in a manufacturing or medical device environment.
• Proficiency in ERP systems (SAP, Epicor, Oracle, or equivalent) and QMS tools.
• Strong data analysis and reporting skills (Excel, Power BI, Tableau preferred).
• Knowledge of regulatory compliance topics (RoHS, REACH, Conflict Minerals, etc.).
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective communication and cross-functional collaboration skills.

Nice To Haves

• Experience with ISO 13485 QMS requirements strongly preferred.

Responsibilities

• Assist with key QMS processes including Document Control, CAPA, Complaints, Nonconforming Product, Internal Audits, and Training.
• Maintain accurate and complete quality system records.
• Help prepare documentation and data for internal and external audits.
• Maintain quality-related modules in the ERP and QMS systems.
• Support users with workflow questions and basic troubleshooting.
• Help improve system workflows and data accuracy as it pertains to quality.
• Create and update quality metrics dashboards (CAPA status, complaint trends, NCR cycles, audit findings, etc.).
• Provide routine reporting for Management Review and operational meetings.
• Prepare Declarations of Conformity (DoCs).
• Complete customer compliance submissions (RoHS, REACH, Prop 65, Conflict Minerals).
• Manage routine activities related to the Assent Compliance Platform.
• Support Quality Systems, Quality Engineering, Supplier Quality, and Operations with system data and reports.
• Provide user training for document control and ERP workflows as they pertain to quality.
• Identify simple process and system improvements.
• Assist in implementing updates to quality system tools or documentation.

Benefits

• Competitive salary
• Generous bonus program tied to performance
• Outstanding benefits package, including Medical/Prescription, FSA, H.S.A., Dental, Vision, STD/LTD and Life/AD&D insurance
• 401k and Financial Services
• Paid Vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level