CAPA Quality Engineer
Now hiring in Dallas, TX.
Job Title: Quality Engineer (CAPA)
Reports to: Quality Manager
Posted Date: August 10, 2018
- 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.
- 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.
- 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.