QMS Sub System Lead Training

At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a QMS Sub System Lead Training.

Position Type:

• Contract
• Remote
  
  
  

Required:

• Bachelor’s degree in a technical or scientific field, or equivalent experience in quality systems within a regulated industry.
• 8 years of experience in Quality Management Systems, preferably within the medical device industry.
• Deep expertise in CAPA processes, investigations, and remediation, including experience addressing regulatory observations or audit findings.
• Strong knowledge of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Proven experience leading cross-functional remediation initiatives or quality system improvement programs across multiple sites or business units.
• Strong analytical, problem-solving, and technical writing skills, with the ability to develop regulatory-ready documentation and reports.
• Excellent communication and leadership skills, with experience presenting to senior leadership and guiding teams in complex quality and compliance initiatives.
  
  
  

Responsibilities:

• Serve as the Subject Matter Expert (SME) for Quality Training processes, providing guidance on training system design, regulatory expectations, and best practices.
• Lead the Training Workstream within the QMS remediation program, addressing compliance gaps and strengthening training processes and systems.
• Support CAPA investigations and remediation activities, including root cause analysis, risk assessments, and development of sustainable corrective actions.
• Implement and monitor interim controls and risk mitigation measures during remediation activities to maintain compliance until permanent solutions are implemented.
• Lead or support the redesign and implementation of training procedures, systems, and records to align with global regulatory requirements.
• Develop and maintain metrics, dashboards, and reporting tools to track remediation progress, training effectiveness, and continuous improvement opportunities.
• Provide training, mentorship, and cross-functional guidance to strengthen adherence to training processes and promote a culture of quality and compliance.
  
  
  

Get in Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Vaibhav at (551) 227-9117 to learn more.

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