Quality Systems Engineer - QMS Focus

Responsibilities

• Act as Corrective Action/Preventive Action (CAPA) administrator by facilitating the (CAPA) system. This includes initiating CAPA’s, overseeing timelines, managing the CAPA log, reporting CAPA related metrics and leading CAPA review board meetings to ensure compliance.
• Manage external audit activities including certification (notified body) audits and customer (contract manufacturing) audits. This consists of taking an active role in the audit process, as well as acting as liaison with external parties, scheduling audits, organizing and facilitating resources, communicating audit responses, maintaining the audit schedule and reporting all audit related metrics.
• Facilitate all internal audit activities. This includes planning, assigning resources, managing the internal audit schedule, and reporting audit related metrics.
• Lead Quarterly Quality Reviews (QQR) used to monitor quality management system (QSM) products and process’. Responsibilities include gathering metric data from various parts of the company, scheduling and facilitating the quarterly meeting to measure and review company performance as it relates to the QMS.
• Gather and manage KPI/metric data used to measure the QMS.
• Assist quality management representative (QMR) in conducting annual quality management reviews per ISO 13485:2016.
• Create and/or update procedures and work instructions to capture improvements to quality management system process’.
• Assist subject matter experts in the development, authoring and releasing of procedures and work instructions used to define their processes.
• Understand, utilize and assist in maintaining document controls and change controls within the QMS.
• Ensure processes and documentation comply with quality system regulations.

• 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 21
  
  CFR
  820 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