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Job #03455

About our client Our Client is a medical device company located in Bohemia NY. They focus on orthodontic systems, services, software and support for medical professionals. With over 40 years of experience, they are leaders in innovative patient care. This is an excellent opportunity for the right candidate to join a fast paced environment! Position Location QA/RA Manager Bohemia NY Salary Highly competitive package, commensurate with experience Responsibilities 1) Manages and monitors all functions with respect to the Quality Assurance Department personnel 2) DCC for all GAC quality procedures (QA Manual, Standard Procedures and Work Instructions) 3) Responsible for Supplier Certification Program as it relates to Quality 4) Management Representative designee for ISO Quality Management Reporting 5) Responsible designee for the Director of Division Compliance & RA 6) Provide ongoing feedback to direct reports and complete annual performance reviews for direct reports 7) Required to perform other duties as requested, directed or assigned Requirements 1) Bachelors Degree in a related field 2) 7 –10 years work experience in Quality field 3) Minimum of 5 years of Supervisory or Management experience in Quality preferred 4) Must have device and 510k experience 5) Must have an understanding of ISO13485