Medical Devices Quality Assurance Lead

hace 1 semana


Ciudad de México, Ciudad de México North American Medical Corporation A tiempo completo

North American Medical Corporation, a world-class manufacturer of spinal orthopedic devices, is seeking a seasoned Quality Assurance professional to lead our team.

About the Role

We are offering a competitive salary of $120,000 - $150,000 per annum, plus benefits, for an experienced QA professional to oversee our quality management systems and ensure compliance with FDA regulations.

Key Responsibilities:

  • Quality Management System Oversight: Ensure adherence to Good Manufacturing Practices (GMP) and ISO 13485:2016 standards.
  • Team Leadership: Manage a team of 6-10 people, providing guidance and mentorship to ensure high-quality work.
  • Process Improvement: Identify areas for improvement and implement changes to enhance operational efficiency and customer satisfaction.
  • Complaint Handling and CAPA: Lead root cause analysis and implement corrective actions to resolve issues.
  • Regulatory Compliance: Ensure ongoing compliance with FDA regulations and maintain up-to-date knowledge of industry developments.
  • Audits and Inspections: Prepare for and participate in internal audits and external inspections, ensuring seamless execution.

Requirements:

  • Experience: At least 7 years in a similar role within Industrial and Medical device sectors.
  • FDA Regulatory Knowledge: Working understanding of FDA regulations and guidelines.
  • Leadership Skills: Proven ability to build and manage high-performing teams.
  • Analytical Skills: Strong analytical skills, comfortable working with numerical data and technical writing.
  • Travel: Willingness to travel approximately once per month.

Benefits:

  • Competitive Salary: $120,000 - $150,000 per annum.
  • Benefits Package: Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Career Growth Opportunities: Exciting career growth opportunities in a growing business.


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