Quality Engineer (Software)

Now hiring in Dallas, TX.

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

Job Description:

  • 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.

 

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 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.