Quality Systems & Training Specialist

QUALITY SYSTEMS & TRAINING SPECIALIST

Santa Rosa, CA $30-$38/hr DOE

Position Summary

Responsible for administering the Learning Management System (LMS) and supporting Quality Management System (QMS) compliance. This position manages employee training, internal audits, auditor certification, Corrective and Preventive Action (CAPA), and complaint processes.

Key Responsibilities

• Administer LMS courses, training plans, enrollment, tracking, and reporting.
• Maintain training materials and employee training records.
• Coordinate internal auditor training and certification.
• Plan and conduct internal QMS audits.
• Maintain audit tools, reports, and documentation.
• Support QMS procedures, work instructions, and continuous improvement.
• Manage CAPA and complaint processes from investigation through closure.
• Track audit findings, CAPA trends, and complaint metrics.
• Maintain QMS records and system modules.
• Collaborate with cross-functional teams on quality issues and investigations.

Qualifications

• High school diploma required; bachelor's degree preferred.
• 2+ years of quality systems experience, including CAPA and complaints.
• Knowledge of internal auditing principles.
• Strong knowledge of ISO 13485 and 21 CFR Part 820.
• Strong problem-solving and analytical skills.
• Excellent communication and organizational skills.
• Proficient with Microsoft Word, Excel, and PowerPoint.
• Ability to manage multiple priorities and projects.
• Medical device or pharmaceutical experience preferred.
• Internal auditing, Green Belt, or project management experience a plus.

Physical Requirements

• Frequent standing, walking, bending, reaching, and other movement.
• Occasional lifting up to 30 pounds.
• Occasional repetitive motion and climbing.
• Must be able to work around typical machine-shop hazards and use required personal protective equipment.