Quality Assurance Lead Auditor

hace 4 días


Juárez, Chihuahua, México Integer Holdings Corporation A tiempo completo

Integer Holdings Corporation

Job Title: Quality Assurance Lead AuditorJob Summary:

We are seeking a highly motivated and experienced Quality Assurance Lead Auditor to support the administration of our Quality Management System. As a key member of our team, you will be responsible for coordinating internal audits, participating in customer and notify body audits, and ensuring compliance with established standards and regulatory requirements.

Responsibilities:
  • Administer the Quality Management System to ensure compliance with ISO 13485, 21 CFR Part 820, COFPERIS, Japan, and Brazil regulatory requirements.
  • Coordinate internal audit processes based on medical device industry requirements.
  • Participate in customer and notify body audits, including audit responses.
  • Collaborate with process owners and department personnel to create, improve, and maintain process documentation.
  • Ensure quality records are administered and controlled according to retention periods.
  • Liaise with clients regarding audit activities and provide management updates on work status, initiatives, and projects.
Requirements:
  • Minimum 3-5 years' experience in GMP audits within the medical device industry.
  • Strong knowledge of medical device quality systems, including 21 CFR Part 820 (QSR) and ISO 13485.
  • Excellent communication and interpersonal skills, with the ability to negotiate and build strong relationships.
  • Maintain a clean and organized work area and promote a culture of continuous improvement.
  • Microsoft Office experience and proficiency in root cause analysis and investigations.
Estimated Salary Range:

$70,000 - $90,000 per year, depending on experience and location.



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