Your responsibilities

• Post Market Surveillance:
• Manage complaint system including intake, facilitation and communicating with the sales force, customer service and regulatory bodies, as required.
• Conduct complaint investigations to determine root cause and reportability requirements.
• Manage and execute post market surveillance duties including product holds, health hazard evaluations (HHE), field actions, and recalls. This includes communicating to appropriate regulatory bodies, as required.
• Generate periodic safety update reports (PSUR) and post market surveillance reviews (PMSR) to support regulatory requirements.
• Distribution Quality: 
• Lead quality engineering efforts as it relates to distribution, logistics and inventory control.
• 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.
• Lead or participate on 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.
• Gather and manage KPI/metric data used to measure the QMS.
• 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.
• Understand, utilize and assist in maintaining document controls and change controls within the QMS.

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