Quality Assurance Associate

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.