The Quality System Lead Auditor assists with all aspects of the internal quality system audit program including audit planning, execution, audit reports , follow-up and re-audit if necessary.
• Fully understand the requirements of the Quality Management System
• Ensure that quality policies and procedures are being adhered to by
• Provide internal communication regarding compliance issues and
applicable regulation changes.
• Aid in creation of gap analysis to any new/changed regulations
• Communicate to management issues that require corrective action
• Maintain files generated from each audit
• Responsible for on-site and off site audit of Quality Management System
• Plan, execute and prepare audits as assigned and complete audit report and follow up actions
• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• FDA or Notified Body experience strongly preferred.
• Must maintain company quality and performance standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Medical Device regulations knowledge and experience is required.
• Bachelor's degree in related field (Engineering, STEM)
• High degree of familiarity with ISO 13485 and 21 CFR 820
• At least seven years of experience in a Quality role with at least two years in quality audit required