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