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.
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.
Masters degree in engineering, science
This is a multinational conglomerate company.

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

AVP, Audit - Quantitative Analytics
Livingston, NJ CIT Group Inc.
Sr R&D Manager - Hazardous Drug Safety
Franklin Lakes, NJ BD (Becton, Dickinson and Company)
Clinical Study Manager -- 8796 : BU ONC US MON...
East Hanover, NJ Ascent
Global Clinical Procurement Manager
Trenton, NJ Alpha Consulting
Assistant Manager, Employee Connections
Secaucus, NJ Vitamin Shoppe Industries Inc
Sr Manager, Commercial Partnerships
Hoboken, NJ John Wiley & Sons, Inc.