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Job #02528

About our client Our client is in the fiel d of human bone and connective tissue processing for transplants and is a world leader in their field. They are also an innovator in the development, manufacturing, and marketing of biological, biometrical, and device systems for musculoskeletal surgery. The company’s present and development-stage technologies address the needs within many musculoskeletal disciplines. Position Location Manager/Director Quality Assurance New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the activities and performance of the Quality Assurance Department, QA specialist, product releases and document control staff with strategic and tactical talent 2) Develop, establish and maintain the quality system 3) Oversee all programs, procedures, processes and controls to improve quality efforts 4) Meet company and departmental quality objectives 5) Lead and manage domestic and international inspection and audit activities and function for the company 6) Ensure that all governmental, industry and international reporting systems comply with regulatory and safety requirements for the company’s products Requirements 1) BS/BA degree, Engineering or Life Science 2) 4-8+ years of experience in quality assurance (i.e. in the medical device, biologics or pharmaceutical industries) 3) Minimum 2-4 years of supervisory experience 4) Sales experience preferred 5) Experience in biologics or combination product strategies preferred 6) Medical device and orthopedic experience preferred 7) Expertise in the development and implementation of a quality management system 8) Strong knowledge of FDA and ISO quality preferred 9) Knowledge of US and international regulations 10) Ability to establish effective relationships with key federal agency personnel 11) Thorough knowledge of human anatomy and scientific methods 12) Experience in compliance and successful conclusion of at least 4 audits 13) Self-motivated with a proactive attitude and ability to work independently 14) Excellent organizational skills