Summary

Supports the creation, development, management, maintenance, control, and overall improvement of the Quality Management System and corresponding processes, procedures, work instructions, and records.

Essential Duties and Responsibilities

• Quality Planning
  • Writes and executes quality plans.
  • Establishes Quality Control points that are used to monitor progress and achievement of quality plans.
• Quality Management System Support
  • Corrective and Preventive Action (CAPA)
    • Performs investigative research and trend analysis of complaints, discrepant material, process control variations, and other quality related issues to understand and identify areas for improvement.
    • Implements corrective or preventive action through formal change control.
  • Complaint Handling
    • Investigates all complaints.
    • Determines if complaints require specific action including but not limited to product recall, adverse event reporting, regulatory notification, etc.
    • Conducts trend analysis to identify reoccurring issues that should be addressed through formal corrective or preventive action or change control.
  • Internal Audits / External Audits
    • Conducts internal audits according to the internal audit schedule or as assigned.
    • Prepares audit checklists, conducts interviews, and records observations, opportunities for improvement, and audit nonconformities in a formal Audit Report.
    • Follows up and clears down all audit nonconformities in future internal audits.
    • Participates in External Audits as assigned.
  • Quality Training
    • Consistently provides quality training to individuals throughout the company.
    • Provides role model behavior regarding adherence to process and procedure.
  • Process Control and Quality Improvement
    • Reviews quality and operational processes including manufacturing and QC to ensure processes are adequately controlled.
    • Prepares appropriatequality controlpointsthroughoutthefacility to provide evidence that processes are in control.
    • Works with department supervisors to identify opportunities for improvement.
    • Implements improvements that reduce variation and improve overall quality.
  • Document Control and Record Control
    • Supports the document control team as assigned.
    • Establishes and maintains records of all actions according to established process and procedure.
• Other
  • Helps to monitor the progress and implementation of quality objectives.
  • Regularly tracks and updates key performance indicators, which are used to assess the overall effectiveness of the Quality Management System.
  • Assists with related special projects, as required.

Qualifications

• Bachelor's degree (B.S.) degree in Life Science or Engineering discipline plus one year quality related experience in manufacturing industry; or three years of direct Quality or Regulatory related experience. Practical experience/training in quality planning, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem solving are highly desirable.
• Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, data base manipulation and flow charts.
• Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality relations.
• This position interfaces with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job position.