Quality Assurance Associate

ELITechGroup Inc. • Logan, UT

2d

About The Position

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

Requirements

• 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.
• 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.
• Confidentiality is important to this job position.

Nice To Haves

• Practical experience/training in quality planning, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem solving are highly desirable.

Responsibilities

• Writes and executes quality plans.
• Establishes Quality Control points that are used to monitor progress and achievement of quality plans.
• 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.
• 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.
• 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.
• Consistently provides quality training to individuals throughout the company.
• Provides role model behavior regarding adherence to process and procedure.
• Reviews quality and operational processes including manufacturing and QC to ensure processes are adequately controlled.
• Prepares appropriate quality control points throughout the facility 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.
• Supports the document control team as assigned.
• Establishes and maintains records of all actions according to established process and procedure.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level