DUTIES AND RESPONSIBILITIES:

  • Manage quality reporting and management review to monitor and analyze system effectiveness across the core business functions as well as utilize data review to identify and drive actions.
  • Lead development, collection, and organization of production quality records and quality system data by taking multiple data streams and identifying important information using advanced organization techniques.
  • Host quality data review meetings on a consistent cadence to identify areas/opportunities for improvement such as recognizing patterns in quality data, identifying meaningful metrics, trends and analysis.
  • Utilize common tools such as statistical process control review, complaint Pareto analysis, Ishikawa diagrams, and statistical data analytics to identify opportunities for improvement.
  • Understand how to utilize Data, Information, Knowledge, Wisdom (DIKW) pyramid within an evolving company to focus efforts and identify opportunities for improvement and growth.
  • Lead collaborative discussions which identify internal and external improvement projects to drive continuous improvement.
  • Lead Quality Systems Management (QMS) development around procurement, vendor development, and production monitoring.
  • Lead cross-functional SOP development both as an architect and a builder within the QMS and outside the QMS. Identify, collaborate, flow business process and write policies, SOPs and work instructions.
  • Utilize CAPA and SCAR systems with a focus on driving continuous improvement execution and monitor the effectiveness of implemented changes.
  • Facilitate and participate in the vendor quality audit function focused on both QMS and system/process effectiveness audits.
  • Transition systems to SPC vendor production monitoring, electronic vigilance including quality review and disposition.
  • Provide guidance and Quality oversight to ensure the establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
  • Ensure controls meet Company and FDA regulatory requirements by actively participating in product development teams and identifying Quality needs, product improvements and customer requirements.
  • Review and assess work performed to help ensure Quality issues with the device(s) or instrument(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
  • Lead and/or participate in Risk Management activities appropriate to the initiative or situation.
  • Work collaboratively and cross-functionally to improve product performance; utilizes troubleshooting and problem-solving skills to identify and eliminate issues that negatively impact product performance.

 

EDUCATION & EXPERIENCE:

  • Bachelors’ degree required; Mechanical Engineering preferred
  • Minimum of 5 years of experience working within a quality function supporting manufacturing/sustaining operations
  • Minimum of 5 years of experience working in an FDA, ISO or automotive/aerospace regulated environment
  • Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820
  • Experience working in an SPC production environment APQP experience preferred
  • Demonstration of applied understanding of statistical analysis and application in change management
  • Excellent people interaction, team building, and communication skills
  • Problem-solving skills with experience in project management to include organization, prioritization, problem-solving, and sound judgment are critical
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