Responsibilities:
⢠Maintain quality metrics at contract manufacturer site toward achievement of pre-defined quality goals. Ensure contract manufacturer compliance to FDA QSR, ISO 13485, and related standards, regulations, and requirements.
⢠Develop and/or manage quality programs/initiatives and ensure its deployment at contract manufacturer site.
⢠Review data and information and make accept/reject decisions about Products, Processes, Validations, etc.
⢠Maintain and track quality for the purposes of analysis, control, cost and management reports.
⢠Investigate product defects, rejects and systems failures with emphasis on corrective action. Provide hands-on leadership to implement failure analysis and corrective actions.
⢠Maintain accurate, timely and efficient inspection and / or complaint processing labs.
⢠Manage effective Material Review Board meetings assure timely disposition and effective corrective action.
⢠Suggest methods for improving product quality, design, or manufacturing processes.
⢠Serve as a team member to provide quality engineering expertise to product development, improvement, or other teams.
⢠Assist with failure and hazard analysis for commercial product, and components.
⢠Supervise quality assurance engineers.
⢠Performs other duties as assigned.