CAPA Quality Engineer

Now hiring in Dallas, TX.

Job Title: Quality Engineer (CAPA)
Reports to:
Quality Manager
Posted Date:
August 10, 2018

Job Description:

  • Data trending and analysis for quality records (including nonconforming product, complaint, customer feedback, and controlled processes).
  • Evaluation and investigation of nonconformities, complaint files, and audit reports.
  • Initiates corrective action requests and tracks to successful completion, including verification of effectiveness.
  • Development and implementation of corrective and preventive action plans, including verification and validation of corrective action plans.
  • Writing test plans, plans for verification and validation and corresponding protocols and reports.
  • Writing and revision of procedures related to quality systems and production processes.
  • Writing training material and conducting training sessions on quality control activities.

 

Training Requirements:

  • Responsible for implementing and maintaining the effectiveness of the quality management system (Nonconforming Product, Complaints, Corrective Actions, Internal Audits, etc. [21 CFR 820]).
  • Employee shall be made aware of and trained on all standard procedures relating to his/her responsibilities.
  • Training required to perform assignments and responsibilities include understanding potential mishaps and methods for recognition and detection.

 

Interrelationships:

  • Works with Quality to evaluate quality data and report trends.
  • Works with Quality to develop and maintain documentation corresponding to investigations and action plans.
  • Works with Quality, Manufacturing and Operations departments to organize and implement corrective actions.
  • Works with all departments to communicate procedural updates and changes to processes.

 

Education/ Skill Requirements

  • Bachelors degree in related field.
  • Demonstrated knowledge and experience in quality regulatory compliance.
  • Strong technical writing skills.
  • Preferred experience working on corrective actions in compliance with 21 CFR 820 or ISO 13485.