Job Location: Brooklyn, NY
Quality Director/Medical Device ISO 13485 Implementation (Experience Required)
> * ISO 13485 Implementation experience required > * Manage QC Department, including staff and laboratory activities. > * Develop QC department protocols and procedures for operation. > * Manage all daily aspects of QC laboratory including but not limited to, testing, instrumentation, release testing of raw materials and finished products. > * Manage and execute analytical method validation. > * Manage and execute QC equipment qualification (IQ,OQ,PQ), with help as needed. > * Manage the review of all quality-related documents. > * Work with VP, QARA and other company leadership to evaluate existing manufacturing practices in terms of cGMP, sterility assurance and regulatory compliance and make recommendations for process improvements. > * Draft job descriptions, company policies, and programs as related to the QC Department. > * Develop and conduct departmental cGMP and SOP training program in coordination with QA Manager. > * Understand and abide by the policies detailed in the...
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Quality Director/Medical Device ISO 13485 Implementation (Experience Required)
> * ISO 13485 Implementation experience required > * Manage QC Department, including staff and laboratory activities. > * Develop QC department protocols and procedures for operation. > * Manage all daily aspects of QC laboratory including but not limited to, testing, instrumentation, release testing of raw materials and finished products. > * Manage and execute analytical method validation. > * Manage and execute QC equipment qualification (IQ,OQ,PQ), with help as needed. > * Manage the review of all quality-related documents. > * Work with VP, QARA and other company leadership to evaluate existing manufacturing practices in terms of cGMP, sterility assurance and regulatory compliance and make recommendations for process improvements. > * Draft job descriptions, company policies, and programs as related to the QC Department. > * Develop and conduct departmental cGMP and SOP training program in coordination with QA Manager. > * Understand and abide by the policies detailed in the...
Apply Now