LMS & QMS Compliance Administrator

SMC•Santa Rosa, CA

54d•$30 - $40

About The Position

Serve as the primary administrator for the Learning Management System (LMS), including course creation, enrollment, and tracking participant progress. Support Quality Management System (QMS) compliance by planning, leading, and conducting internal audits; coordinating internal auditor certification and training; and facilitating audits with corporate, third-party, customer, registrar, and regulatory bodies. Oversee the Corrective and Preventive Action (CAPA) and Complaint processes, ensuring timely investigation, resolution, and closure of findings through effective collaboration and coordination with CAPA owners. The role administers learning plans, courses, and training schedules; maintains learning materials; responds to training inquiries; evaluates training effectiveness; and reports on participation, completion, and program impact. It also maintains audit tools and documentation, supports QMS procedure improvements, monitors audit results, CAPA trends, and complaint metrics, and oversees QMS system modules related to audits, CAPA, and complaints. Additional quality and compliance responsibilities may be assigned.

Requirements

High school diploma or equivalent required.
Minimum of 2 years of experience in quality systems, such as CAPA or complaints management.
Knowledge of internal auditing principles and practices.
Strong understanding of ISO 13485 and 21 CFR Part 820 regulatory requirements.
Problem-solving and CAPA analysis skills.
Excellent verbal and written communication skills and ability to collaborate across departments with peers and leadership.
Working knowledge of Microsoft Word, Excel, and PowerPoint, plus strong general computer skills.
Strong time management and organizational abilities, including planning, prioritizing, and following through on multiple tasks.
Ability to coordinate cross-functional teams and manage multiple projects or investigations simultaneously.
Ability to learn quickly and adapt to new systems and platforms.
Ability to stand, walk, bend, squat, twist, reach, or otherwise move frequently; occasional repetitive motion, grasping, and climbing; and lift, move, or transfer loads as described in the ADA requirements.
May be exposed to typical machine shop physical hazards that may require respiratory protection.

Nice To Haves

Bachelor’s degree preferred.
Experience in a medical device or pharmaceutical regulated industry.
Green belt training or certification.
Internal auditing experience.
Project Management training.

Responsibilities

Administer and manage learning plans, courses, and training schedules to ensure completion of mandatory and ongoing programs.
Maintain and update training materials and resources.
Respond to employee training-related inquiries.
Collect participant feedback, analyze results, and implement improvements to training effectiveness.
Generate and present reports on participation, completion rates, and program impact.
Plan, lead, and conduct internal audits to verify compliance with QMS requirements and applicable corporate, customer, third-party, and regulatory expectations.
Develop and maintain audit tools, checklists, and documentation.
Coordinate internal auditor training and certification programs.
Assist in developing and revising QMS procedures and work instructions.
Administer CAPA and Complaint processes, ensuring timely investigation, resolution, and closure in accordance with established procedures.
Monitor, analyze, and report on audit results, CAPA trends, and complaint metrics to identify risks and improvement opportunities.
Oversee QMS system modules related to audits, CAPA, and complaints to support accurate recordkeeping and effective processes.
Perform additional quality and compliance responsibilities as assigned.