ISO 13485 Training Program Clerk

• Maintain a paper-based training system compliant with ISO 13485, ensuring document control and traceability
• Track training completion, retraining intervals, and effectiveness; maintain metrics and reports for leadership and audits
• Prepare audit-ready training records; support internal/external audits and address training-related CAPAs
• Design/maintain a tiered/hierarchical training model (entry → qualified → trainer-level) with competencies, skill matrices, and qualification paths
• Collaborate with Manufacturing, Quality, and HR to align training with processes, SOPs, and system changes
• Develop and administer dual-language training material updates (English/Spanish); coordinate translation and verification.

ISO 13485 Training Program Clerk Job Qualifications:

• 3+ years in training coordination, quality systems, or manufacturing operations in a regulated environment
• Working knowledge of ISO 13485 training and documentation requirements (or similar QMS standards)
• Strong recordkeeping discipline, attention to detail, and audit-readiness mindset
• Experience building skill matrices and competency-based qualification paths
• Effective written and verbal communication; ability to create clear, practical training content
• Proficiency with Microsoft Office Workspace; comfort with data tracking/reporting

Preferred:

• Experience with IQMS (training/qualification or document control modules)
• Experience creating interactive or video-based training content under document control

** THIS IS A 3 MONTH LONG PROJECT
** that may be extended.