Your responsibilities

Lead quality engineering efforts as it relates to distribution, logistics and inventory control including managing non-conformances. Utilize ERP systems to insure inventories are properly managed as it relates to quality initiated actions. Assist in developing and improving distribution related processes, methods and procedures. Participate and/or lead CAPA teams regarding quality system related non-conformances. Assist subject matter experts (SME) in the development, authoring and releasing of procedures and work instructions used to define processes. Review changes for conformance to the quality system and regulatory agencies. Gather and manage KPI/metric data used to measure the QMS. Participate in Post Market Surveillance and complaint activities. Contribute on new product development projects as it pertains to quality related inputs and approvals. Engage in both internal and external audits as a member of audit teams. Continuously improve procedures, and work instructions to meet standards and regulations as well as accurately represent our processes. Understand, utilize and assist in maintaining document controls and change controls within the QMS. Ensure processes and documentation comply with quality system regulations. All other duties as assigned by manager or leadership team. Your qualifications

BS in Engineering or related field preferred, or equivalent in experience and training Working knowledge of the medical device regulated industry, to include ISO 13485 and FDA 21CFR820 regulations Basic knowledge of statistical and engineering principals Strong analytical and problem solving skills Strong proficiency in root cause analysis to include tools and methodology Proficient in Microsoft Office applications What we offer

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.