Job Summary:
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 to 30lbs. 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
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Skills Required
- High School diploma or equivalent
- Minimum 2 years experience in quality systems (CAPA, complaints management)
- Knowledge of internal auditing principles and practices
- Strong understanding of ISO 13485 and 21 CFR Part 820 regulatory requirements
- Proven problem-solving skills and CAPA analysis
- Excellent verbal and written communication skills
- Working knowledge of Microsoft Word, Excel, and PowerPoint
- Strong time management and organizational abilities
- Ability to coordinate cross-functional teams and manage multiple projects/investigations
- Quick learner with ability to adapt to new systems and platforms
- Bachelor's degree
- Experience in a Medical Device or Pharmaceutical regulated industry
- Green Belt training/certification
- Internal auditing experience
- Project management training
What We Do
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries. Services include design, engineering, thermoplastic molding including insert, two-shot and micro, liquid silicone injection molding (LIM) and complete device assembly. Project integration, supply chain management, validation, packaging and labeling, and sterilization responsibility are systematically controlled. Facilities offer ISO 13485, quality systems, white room, class 7 and 8 clean rooms. SMC Group: Oval Medical Technologies, an SMC Ltd. company, is a medical device company developing in revolutionary autoinjector platforms. Oval’s unique approach allows for devices that are smaller, easier and safer to use than any other device currently available. Pharmaceutical partners can utilise Oval’s technology to deliver viscous formulations and sensitive biological drugs that would otherwise not be possible to deliver in current marketed injectable devices. Oval is able to tailor the technology for specific patient populations producing devices that are truly patient centric. www.ovalmedical.com
