Quality Engineer (CAPA)

Now hiring in Dallas, TX.

Job Title: Quality Engineer (CAPA)

Reports to: Quality Manager

Prepared Date: October 14, 2019

Job Description:

  • Issuing and ensuring timely completion of corrective and preventive actions, including associated risk evaluation and validation activities.
  • Continuously improve quality operation procedures and maintain procedural compliance.
  • Ensure adequate investigations and implementation, including appropriate statistical trending and root cause analysis for corrective actions.
  • Training and facilitation of quality operations throughout the organization, including implementation of corrective actions and sourcing of appropriate data from other teams into the Quality system.
  • Identification of equipment and processes needing validation; and development and execution of corresponding validation protocols and reports (including IQ, OQ, and PQ).
  • Provide support for design controls and risk management relative to product development.
  • Serves as quality representative in the development of new products. Ensures the establishment of critical features, inspection, and testability of new products.
  • Drives implementation of quality processes (complaints, nonconformance, corrective actions, change control, internal auditing, etc.)
  • Supports data preparation for semi-annual QMS Management Reviews.
  • As requested, other support Quality System 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 within Quality to ensure the maintenance of Quality processes. 
  • Works with Manufacturing to ensure that data is used towards the improvement of production processes.  
  • Works with Engineering to ensure inspection controls for newly developed product.

Education/ Skill Requirements

  • BS degree in engineering or science.
  • Minimum 1 year experience working within a Quality system.
  • Strong communication and technical writing skills.
  • Ability to work effectively in team situations as well as independently.
  • Preferred knowledge of 21CFR 820 and ISO 13485 standards.