Quality Assurance Lead Auditor
hace 4 días
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.
- 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.
$70,000 - $90,000 per year, depending on experience and location.
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