Job Description

SMC Ltd. was developed around a commitment to its people and customers. This continued as a global leader in contract manufacturing for medical device, diagnostics and drug delivery companies. Located in beautiful Santa Rosa, CA, SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people. In the role of the LMS/QMS Compliance Administrator, you will serve as the primary administrator for the Learning Management System (LMS), including course creation, enrollment, and tracking of 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. Essential Job Duties and Responsibilities: LMS (Learning Management System): Administer and manage learning plans, courses, and training schedules to ensure completion of all mandatory and ongoing programs. Maintain and update training materials and resources to provide employees with accessible, accurate, and effective learning content. Support employee engagement by providing timely responses to training-related inquiries. Evaluate and enhance training effectiveness by collecting participant feedback, analyzing results, and implementing improvements. Generate and present reports on participation, completion rates, and program impact to support data-driven decision making. QMS (Quality Management System): Plan, lead, and conduct internal audits to verify compliance with QMS requirements and corporate, customer, third-party, and regulatory expectations. Develop and maintain audit tools, checklists, and documentation to ensure consistency and traceability. Coordinate internal auditor training and certification programs to build and sustain audit readiness. Drive continuous improvement by assisting in the development and revision of QMS procedures and work instructions. Administer the Corrective and Preventive Action (CAPA) and Complaint processes, ensuring timely investigation, resolution, and closure in compliance with established procedures. Monitor, analyze, and report on audit results, CAPA trends, and complaint metrics to identify risks and opportunities for improvement. Oversee QMS system modules related to audits, CAPA, and complaints to ensure accurate recordkeeping and process effectiveness. Perform additional quality and compliance responsibilities as assigned. Essential Qualifications: Bachelor’s degree preferred; High School Diploma or equivalent required with a minimum of 2 years of experience in quality systems (e.g., CAPA, complaints management). Knowledge of internal auditing principles and practices. Strong understanding of ISO 13485 and 21 CFR Part 820 regulatory requirements. Proven skills in problem-solving and CAPA (Corrective and Preventive Action) analysis. Excellent verbal and written communication skills; able to collaborate effectively with peers and leadership across departments. Working Knowledge in Microsoft Word, Excel, and PowerPoint, with strong general computer skills. Strong time management and organizational abilities, with the capacity to plan, prioritize, and follow through on multiple tasks. Demonstrated ability to coordinate cross-functional teams and manage multiple projects or investigations simultaneously. Quick learner with the ability to adapt to new systems and platforms. Desirable Qualifications: Experience in a Medical Device or Pharmaceutical regulated industry a plus. Green belt training/certification Internal auditing experience Project Management training ADA Requirements: Stand, walk, bend, squat, twist, reach or otherwise move frequently Occasional repetitive motion and grasping Occasional climbing to reach areas on machines or racks Lift, move or otherwise transfer up to30lbs. occasionally, >20. frequently Typically sits, grasps items or performs keyboarding for occasional operation of a computer Exposure to typical machine shop physical hazards which may require respiratory protection We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range. Hourly salary range is $30.00 - $40.00 per hour. This is not a remote position and will be on-site Mon. - Fri., 8:00 AM - 5:00 PM #IND

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