Senior QMS Specialist - eQMS, CAPA & Audits

Free Market Health

Pittsburgh (Allegheny County)

On-site

USD 120,000 - 160,000

Full time

5 days ago
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Benefits offered by this job

Unlimited PTO
100% employer-paid medical, dental, &

Job summary

Free Market Health, based in Pittsburgh, PA, seeks a Senior Quality Management Systems Specialist to drive day-to-day QMS operations and continuous improvement across the organization. You will coordinate eQMS administration, document control, CAPA, audits, training, and supplier quality activities to support patient-centric care and business excellence.

You will collaborate with cross-functional teams, validate systems, develop dashboards, and ensure regulatory readiness in a healthcare tech

Qualifications

  • Hands-on experience with electronic Quality Management Systems (eQMS) and quality documentation.
  • Experience with CAPA, deviations, audits, document control, and change management.
  • Knowledge of healthcare, health tech, SaaS, or other regulated environments.
  • Proficiency with quality reporting tools and data analysis.

Responsibilities

  • Serve as administrator and SME for the electronic Quality Management System (eQMS).
  • Maintain workflows, forms, templates, user roles, permissions, and security settings.
  • Coordinate system changes, upgrades, patches with vendors, IT, and Quality leadership.
  • Support system validation and testing activities.
  • Develop and maintain eQMS dashboards, reports, metrics, and data extracts.
  • Monitor data quality and workflow effectiveness.
  • Coordinate vendor support and enhancement requests.
  • Support implementation of new quality processes and eQMS modules.
  • Coordinate the full document lifecycle and ensure controlled documents remain current.
  • Maintain audit-ready records and access controls.
  • Train employees on document control and records-management processes.
  • Coordinate deviations, non-conformances, and CAPAs from intake to closure.
  • Manage customer and patient complaint resolution and root-cause analyses.
  • Prepare CAPA and quality-performance reports.
  • Execute quality training programs and oversee LMS functionalities.
  • Develop training content, curricula, and role-based training.
  • Produce compliance and training reports; track overdue requirements.

Skills

Quality management
eQMS administration
CAPA management
Audits
Documentation control
Regulatory compliance

Education

Bachelors degree in related field

Tools

eQMS software
Microsoft Office

Job description

Free Market Health, based in Pittsburgh, PA, seeks a Senior Quality Management Systems Specialist to drive day-to-day QMS operations and continuous improvement across the organization. You will coordinate eQMS administration, document control, CAPA, audits, training, and supplier quality activities to support patient-centric care and business excellence.

You will collaborate with cross-functional teams, validate systems, develop dashboards, and ensure regulatory readiness in a healthcare tech

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