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