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Quality Assurance Audit Manager

Company Name:
Koch Davis
Plan and conduct scheduled and non scheduled medical device regulatory compliance audits according to the audit plan to ensure compliance with all pertinent regulations, standards, and company policies. Conduct audit closing meetings to review and report audit findings to appropriate stakeholders. Utilize working knowledge of compliance best practices to make recommendations for process improvements as needed. Maintain knowledge of worldwide regulatory requirements, quality management systems, and corporate policies. Keep abreast of regulatory and industry trends and ensures company takes a proactive approach to meet these requirements. Develop and execute trainings program regarding FDA, ISO, and other worldwide regulatory requirements for internal and external staff.
Requirements
Minimum 6 years of experience in a quality assurance, engineering, operations, and regulatory affairs role within an FDA regulated company. Strong working knowledge of worldwide cGMPs, regulatory requirements, standards, and quality management systems. Experience working with regulating authorities. Previous experience in planning and executing risk based quality assurance and regulatory affairs compliance audits of medical device R&D and manufacturing facilities to identify regulatory compliance issues.
Education
Masters degree in engineering, science
Client
This is a multinational conglomerate company.

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