Quality Assurance Manager

Company: The Davis Companies
Location: Rancho Cucamonga
Posted on: May 13, 2022

Job Description:

The Davis Companies is partnering with a large medical device manufacturer in Rancho Cucamonga, CA who is searching for a Quality Assurance Manager. - This person -will manage the Quality Assurance team to support a compliant Quality Management System. - This includes document control, inspection, CAPA, complaints, training, supplier quality management, calibration, product/process monitoring, and design control.RESPONSIBILITIES OF THE QUALITY ASSURANCE MANAGER--- - - - - - - - - - - - Develop, Maintain and Responsible for a Quality Management System (QMS) that is complaint to FDA requirements, EU, Canada and ISO regulations--- - - - - - - - - - - - Follow all regulations, standards, procedures, and work instructions defined in the Quality System Manual and insure the QMS is compliant to all current regulations--- - - - - - - - - - - - Report the status of the QMS to top management--- - - - - - - - - - - - Management Representative for FDA and ISO--- - - - - - - - - - - - Manage Quality team including annual perform performance reviews--- - - - - - - - - - - - Assign Quality job responsibilities and projects to appropriate employee to support compliance--This includes, but is not limited to: document control, complaints, CAPAs, training, NMR's, inspection, calibration, supplier approval, supplier audits, deviations, returned merchandise, certificates of compliance, sterilization, sterilization validations, sterile product release, internal audits, management review, product bioburden, dose audits, product monitoring, process monitoring, design activities, cleanroom certification, etc.--- - - - - - - - - - - - Support Engineering and Manufacturing through the change activitiesREQUIREMENTS OF THE QUALITY ASSURANCE MANAGER:--- - - - - - - - - - - - Bachelor's degree or equivalent education and 5 years+ of Quality Management, Quality Assurance and Regulatory compliance to the FDA, ISO, & Health Canada regulations.--- - - - - - - - - - - - Good understanding of the FDA GMP & ISO-13485 (FDA/ISO 13485 auditor training preferred).--- - - - - - - - - - - - Good working knowledge of the international medical standards.--- - - - - - - - - - - - Good working knowledge of sterilization validations.DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. -We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. -Apply today and experience "The DAVIS Difference". -#PIQACCPandoLogic. Keywords: Quality Control / Quality Assurance Manager, Location: Rancho Cucamonga, CA - 91729

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