Quality Engineer (Software)
Now hiring in Dallas, TX.
Job Title: Quality Engineer (Software)
Reports to: Quality Manager
Posted Date: August 10, 2018
- Ensure that software systems used in production and in support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.
- Writing test plans, validation protocols, leading execution of validation, and generating corresponding reports.
- Revision control and documentation of software used in production processes.
- Provide support for design controls and risk controls relative to software development.
- Identification and development of test plans for equipment and processes needing validation.
- Writing and revision of procedures related to quality systems and production processes.
- Writing training material and conducting training sessions on Quality and Operations 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 develop and maintain documentation that demonstrates control of software systems.
- Works with Operations to select and validate software used for production.
- Works with Engineering, Quality, and Operations to maintain controls over approved/ validated software used for production.
Education/ Skill Requirements
- Bachelors degree in related field.
- Minimum 3 years’ experience validating software in compliance with 21 CFR 820 or ISO 13485.
- Strong technical writing skills.
- Preferred experience with software development.