ISO 13485 Training Program Clerk Job Responsibilities:
- 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)
- Bilingual English/Spanish or experience developing bilingual materials
- Experience creating interactive or video-based training content under document control
**THIS IS A 3 MONTH LONG PROJECT** that may be extended.
CS-ELK
Resumes can be sent to jobs@completestaff.net