Sr. Quality Management Systems Specialist

Posted 18 Hours Ago
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Pittsburgh, PA, USA
In-Office
Senior level
Healthtech
The Role
Administer and improve the enterprise electronic Quality Management System, including document control, CAPA, deviations, audits, training, vendor qualification, risk management, and change control. Maintain workflows, records, dashboards, metrics, and system access; coordinate quality activities across departments and vendors; support audit readiness, software validation, corrective actions, and management reporting. Partner with Quality, IT, HR, Security, Operations, and business leaders to ensure compliance and continuous process improvement.
Summary Generated by Built In

Why FMH
Every day, someone receives a life-changing diagnosis. Getting the right medication should be straightforward - but too often it isn’t.

Specialty medications move through a complex network of providers, health plans, pharmacies, and manufacturers. Administrative delays, disconnected systems, and limited visibility can slow treatment when time matters most.

Free Market Health exists to make that process work better.

Our technology connects stakeholders across the specialty pharmacy ecosystem, helping prescriptions reach the right pharmacy while improving visibility, reducing friction, and keeping treatment moving forward for the patients who depend on them. We focus on the most important stakeholder of all: the patient.

Your impact

Free Market Health is seeking a Senior Quality Management Systems Specialist to support the day-to-day execution and continuous improvement of our enterprise Quality Management System. This role will coordinate 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, you will serve as a key subject matter expert and operational partner for the quality function. The ideal candidate brings hands-on experience supporting quality systems in healthcare, health technology, SaaS, or another regulated environment. You should be highly organized, comfortable working across teams, and motivated by the opportunity to strengthen quality processes that support patient-centered care and business excellence.


What You’ll Do

Administer Electronic Quality Systems

  • Serve as an administrator and subject matter expert for the electronic Quality Management System, or eQMS.
  • Maintain system workflows, forms, templates, user roles, permissions, security settings, and user accounts.
  • Coordinate system configuration changes, upgrades, patches, and enhancements with software vendors, IT, and Quality leadership.
  • Support system validation and testing activities.
  • Develop and maintain eQMS dashboards, reports, metrics, and data extracts.
  • Monitor system performance, data quality, and workflow effectiveness.
  • Serve as the primary contact for routine vendor support, issue resolution, and enhancement requests.
  • Support the implementation of new quality processes and eQMS modules.

Support Document and Records Control

  • Coordinate the full document lifecycle, including creation, review, approval, distribution, archival, and retirement.
  • Ensure controlled documents remain current, version-controlled, and accessible to authorized employees.
  • Coordinate recurring document reviews and track required updates.
  • Maintain audit-ready records, electronic signature governance, and appropriate system access controls.
  • Recommend process and policy updates in response to regulatory changes, customer requirements, and evolving industry practices.
  • Train and assist employees with document control and records-management processes.

Coordinate Deviations, Non-Conformances, and CAPAs

  • Coordinate deviation and non-conformance activities from intake and investigation through disposition and closure.
  • Support the management and resolution of customer and patient complaints across operational teams.
  • Facilitate structured root cause analyses.
  • Coordinate CAPA initiation, assignment, effectiveness reviews, and closure.
  • Monitor CAPA aging, trends, overdue actions, and other performance measures.
  • Partner with cross-functional teams to support the timely completion and validation of corrective actions.
  • Prepare CAPA and quality-performance reports.

Manage Quality Training Activities

  • Execute quality training programs and oversee learning management functionality within 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 and follow up on overdue requirements.
  • Partner with Human Resources, Security, Operations, and department leaders to align training with onboarding, job changes, regulatory requirements, and customer expectations.
  • Evaluate training effectiveness and recommend improvements.

Support Audit Readiness

  • Coordinate and execute quality audit program activities under the supervision of the Vice President of Quality & Compliance.
  • Support internal, supplier, customer, and regulatory audits.
  • Coordinate audit planning, scheduling, logistics, and documentation.
  • Conduct internal audits and document findings in accordance with established procedures.
  • Track audit findings, corrective actions, and supporting evidence through closure.
  • Maintain audit records within the eQMS and support ongoing inspection readiness.

Monitor Quality Risk and System Performance

  • Support quality risk assessments, risk registers, and periodic reviews.
  • Facilitate the use of established 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.

Support Vendor Quality Management

  • Coordinate vendor qualification and supplier quality activities, including risk assessments and document reviews.
  • Maintain approved vendor lists and qualification records within the eQMS.
  • Prepare vendor performance data, KPI tracking, and scorecard reporting.
  • Support vendor audits and manage resulting findings through closure.
  • Monitor supplier quality obligations and corrective actions.
  • Escalate supplier quality issues and trends when appropriate.

Coordinate Change Control

  • Facilitate change control activities involving systems, processes, equipment, facilities, and documentation.
  • Manage change records 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 while monitoring aging items.
  • Confirm that validation requirements and supporting documentation are completed for applicable changes.
  • Maintain change-control metrics, trend analyses, and continuous-improvement recommendations.


What We’re Looking For

  • Bachelor’s degree in a related field preferred. An associate degree combined with equivalent professional experience will also be considered.
  • 3+ years of relevant experience with a bachelor’s degree, or 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.
  • A 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.

 

Life at FMH

We’re building more than a company. We’re building a team of ambitious, curious people who are passionate about solving meaningful problems, growing their careers, and genuinely enjoying the journey together. 

Based in Pittsburgh’s Strip District, FMH draws inspiration from the city we call home. Our value of Grit isn’t just a word on a wall. It’s a mindset inspired by the city around us: showing up, rolling up our sleeves, and finding a way forward no matter the challenge. 

As FMH continues to grow, so do the opportunities for our people to leave their mark. Guided by our core values  of Integrity, Adaptability, Grit, and Collaboration, we foster an environment where trust is earned, new ideas are welcomed, challenges are embraced, and success is shared.  You will be surrounded by people who care deeply about the work they do and the people they do it with.

Together, we’re building something special, and we’re just getting started. 

Benefits

  • Unlimited PTO
  • 100% employer-paid individual medical, dental, and vision premiums
  • Employer HSA contribution
  • Paid parental leave
  • 401(k) match
  • Transportation and parking benefits
  • Flexible, collaborative work environment

 Benefit eligibility is based on employment status.



Build What’s Next With Us

Healthcare is evolving - and so are we.

If you’re excited by meaningful challenges, collaborative teammates, and the opportunity to help build a growing healthcare technology company, we’d love to hear from you.

Equal Opportunity Employer

Free Market Health is proud to be an Equal Opportunity Employer.

We believe that  a diverse and inclusive workplace makes us better teammates and problem solvers and we encourage all qualified individuals to apply. Employment decisions are based on business needs, qualifications, and merit.

FMH is also committed to providing reasonable accommodations throughout the hiring process. If you require assistance or accommodation due to a disability, we will work with you to meet your needs.

Skills Required

  • Bachelor’s degree in a related field
  • Associate degree combined with equivalent professional experience
  • 3+ years of relevant experience with a bachelor’s degree
  • 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
  • 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
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The Company
HQ: Pittsburgh, PA
46 Employees
Year Founded: 2019

What We Do

Founded in 2019 and headquartered in Pittsburgh, PA, Free Market Health supports forward-thinking payers and specialty pharmacies of all sizes who need to operate in a complex and opaque market. We empower all stakeholders to optimize resources and maximize opportunities while focusing on the most important stakeholder of all: the patient.

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