Quality Engineer (CAPA)
Now hiring in Dallas, TX.
Job Title: Quality Engineer (CAPA)
Reports to: Quality Manager
Prepared Date: October 14, 2019
- 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.
- 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 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.