The Role
Leads training compliance and qualification programs within a regulated medical device manufacturing environment. Develops compliant curricula, oversees training records and LMS processes, monitors completion and effectiveness metrics, supports remediation and audit readiness, and collaborates with Quality, Operations, Regulatory Affairs, Engineering, and project teams. Drives continuous improvement, governance, documentation compliance, and corrective actions while presenting compliance dashboards and reports to stakeholders.
Summary Generated by Built In
QRC Group is seeking an experienced Training Compliance Manager to support a critical remediation initiative at a leading global medical device manufacturer in El Paso, Texas. The selected professional will lead training compliance activities to ensure employees are properly qualified; training programs meet regulatory requirements, and documentation practices align with quality system standards. The Training Compliance Manager will play a critical role in strengthening compliance, improving workforce qualification processes, and ensuring sustainable adherence to quality and regulatory requirements.
This role will serve as a key liaison between Quality, Operations, Regulatory Affairs, and Project Teams to strengthen training governance, improve compliance processes, and support sustainable remediation efforts within a highly regulated manufacturing environment.
Responsibilities
- Lead training compliance activities associated with remediation and quality improvement initiatives.
- Develop and maintain compliant training strategies, curricula, and qualification programs for impacted personnel.
- Ensure training programs meet internal quality standards and applicable regulatory requirements.
- Oversee the creation, review, approval, and maintenance of training materials and records.
- Monitor training effectiveness through assessments, qualification metrics, and compliance audits.
- Track training completion, overdue assignments, and employee qualification status.
- Support gap assessments and remediation activities related to training and documentation compliance.
- Collaborate with Quality, Operations, Engineering, and Subject Matter Experts to ensure training requirements are effectively implemented.
- Participate in internal audits, regulatory inspections, and quality reviews related to training systems and employee qualifications.
- Drive continuous improvement initiatives to enhance training processes, learning effectiveness, and compliance performance.
- Support governance activities, training review cycles, and change management efforts associated with new procedures, workflows, and documentation requirements.
- Generate and present compliance metrics, dashboards, and status reports to project leadership and stakeholders.
Requirements
- Bachelor’s degree in Life Sciences, Education, Engineering, Business Administration, Organizational Development, or a related field.
- Minimum of 5 years of experience supporting training compliance, quality systems, or learning management processes within a regulated industry.
- Experience working in Medical Device, Pharmaceutical, Biotechnology, or FDA-regulated manufacturing environments.
- Strong knowledge of training systems, qualification processes, and compliance requirements.
- Experience managing training records, curricula, learning management systems (LMS), and employee qualification programs.
- Understanding of Good Documentation Practices (GDP), Quality Management Systems (QMS), and regulatory expectations.
- Strong project management, organizational, and stakeholder management skills.
- Excellent written and verbal communication skills.
- Ability to analyze training compliance data and implement corrective actions when necessary.
- Willingness to work in El Paso, Texas.
Preferred Qualifications
- Experience supporting large-scale remediation, inspection readiness, or compliance improvement projects.
- Familiarity with FDA regulations, ISO 13485, and medical device quality systems.
- Experience with Learning Management Systems (LMS) within regulated environments.
- Certification in Quality, Compliance, Training, Lean Six Sigma, or Project Management.
- Experience leading training governance and audit readiness initiatives.
Key Competencies
- Training Compliance Management
- Quality Systems & Regulatory Compliance
- LMS Administration & Training Records
- Audit Readiness & Inspection Support
- Remediation Program Support
- Training Effectiveness & Qualification Management
- Continuous Improvement
- Stakeholder Engagement
- Documentation Compliance
- Project Leadership
Skills Required
- Bachelor's degree in Life Sciences, Education, Engineering, Business Administration, Organizational Development, or a related field
- At least 5 years of experience supporting training compliance, quality systems, or learning management processes within a regulated industry
- Experience in medical device, pharmaceutical, biotechnology, or FDA-regulated manufacturing environments
- Knowledge of training systems, qualification processes, and compliance requirements
- Experience managing training records, curricula, learning management systems, and employee qualification programs
- Understanding of Good Documentation Practices, Quality Management Systems, and regulatory expectations
- Strong project management, organizational, and stakeholder management skills
- Excellent written and verbal communication skills
- Ability to analyze training compliance data and implement corrective actions
- Willingness to travel within the US-East region as required
- Experience supporting large-scale remediation, inspection readiness, or compliance improvement projects
- Familiarity with FDA regulations, ISO 13485, and medical device quality systems
- Experience with Learning Management Systems within regulated environments
- Certification in Quality, Compliance, Training, Lean Six Sigma, or Project Management
- Experience leading training governance and audit readiness initiatives
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
