Sr. Quality Management Systems Specialist

FreeMarketHealth•Pittsburgh, PA

17h

About The Position

Free Market Health is seeking a Senior Quality Management Systems Specialist to support the day-to-day execution and continuous improvement of its enterprise Quality Management System. The role coordinates essential quality activities across the organization, including electronic quality system administration, document and records control, corrective and preventive action, deviation management, audits, employee training, vendor qualification, change control, and quality risk management. Reporting to the Vice President of Quality & Compliance, the Specialist serves as a key subject matter expert and operational partner for the quality function. The position supports quality systems in healthcare, health technology, SaaS, or another regulated environment and works across teams to strengthen quality processes that support patient-centered care and business excellence. Responsibilities also include administering and improving the eQMS; coordinating document, record, deviation, non-conformance, CAPA, training, audit, risk, vendor-quality, and change-control activities; maintaining quality data and reports; and identifying process-improvement opportunities.

Requirements

Bachelor’s degree in a related field, or an associate degree combined with equivalent professional experience.
At least 3 years of relevant experience with a bachelor’s degree, or at least 5 years of relevant experience with an associate degree.
Practical experience with electronic Quality Management Systems, CAPA, deviations, audits, document control, and change management.
Knowledge of healthcare, health technology, SaaS, or another regulated environment.
Familiarity with learning management systems, quality training, risk management, and software validation.
Proficiency with Microsoft Office and quality reporting tools.
Strong analytical, organizational, communication, and problem-solving skills.
Ability to manage multiple priorities while maintaining accuracy and attention to detail.
Demonstrated ability to collaborate effectively across departments.
Commitment to quality, compliance, and positive patient outcomes.

Nice To Haves

Lean, Six Sigma, or American Society for Quality certification.
Experience supporting inspections, regulatory audits, or customer audits.
Experience developing quality dashboards, trend analyses, or management review materials.

Responsibilities

Administer the electronic Quality Management System (eQMS), including workflows, forms, templates, user roles, permissions, security settings, and accounts.
Coordinate eQMS configuration changes, upgrades, patches, enhancements, validation, testing, and implementation of new quality processes or modules.
Develop and maintain eQMS dashboards, reports, metrics, and data extracts; monitor system performance, data quality, and workflow effectiveness.
Act as the primary contact for routine eQMS vendor support, issue resolution, and enhancement requests.
Coordinate the document lifecycle, including creation, review, approval, distribution, archiving, retirement, recurring reviews, and updates.
Maintain current, version-controlled documents, audit-ready records, electronic signature governance, and appropriate system access controls.
Recommend document-control process and policy updates in response to regulatory changes, customer requirements, and industry practices; train and assist employees in document and records management.
Coordinate deviations and non-conformances from intake and investigation through disposition and closure, and support resolution of customer and patient complaints.
Facilitate root cause analyses and coordinate CAPA initiation, assignment, effectiveness reviews, closure, and performance reporting.
Monitor CAPA aging, trends, overdue actions, and performance measures; partner with teams to complete and validate corrective actions on time.
Execute quality training programs and oversee learning-management functionality in the eQMS and other Quality-administered systems.
Develop and maintain training content, curricula, and assignments; coordinate role-based training and monitor completion across departments.
Produce training compliance reports, follow up on overdue requirements, and evaluate training effectiveness and recommend improvements.
Coordinate with Human Resources, Security, Operations, and department leaders to align training with onboarding, job changes, regulatory requirements, and customer expectations.
Coordinate and execute quality audit program activities under the supervision of the Vice President of Quality & Compliance.
Support internal, supplier, customer, and regulatory audits by coordinating planning, scheduling, logistics, and documentation; conduct internal audits and document findings.
Track audit findings, corrective actions, and evidence through closure; maintain audit records in the eQMS and support inspection readiness.
Support quality risk assessments, risk registers, periodic reviews, and the use of risk-management tools across quality and operational processes.
Maintain quality dashboards, metrics, and trend analyses; prepare management-review materials and executive-level quality reporting.
Identify and recommend opportunities to improve QMS processes.
Coordinate vendor qualification and supplier quality activities, including risk assessments and document reviews.
Maintain approved vendor lists and qualification records in the eQMS; prepare vendor performance data, KPI tracking, and scorecard reporting.
Support vendor audits, manage findings through closure, monitor supplier quality obligations and corrective actions, and escalate supplier issues and trends when appropriate.
Facilitate change control for systems, processes, equipment, facilities, and documentation from initiation and impact assessment through approval, implementation, and closure.
Coordinate assessments of regulatory, validation, training, and documentation impacts; facilitate cross-functional reviews and approvals and monitor aging items.
Confirm validation requirements and supporting documentation are completed for applicable changes, and maintain change-control metrics, trend analyses, and continuous-improvement recommendations.