Process Engineer

Now hiring in Dallas, TX.

Job Title: Process Engineer
Reports to:
Quality Manager
Posted Date:
August 10, 2018

Job Description:

  • Using risk management approach to develop workflow, work station, and equipment improvement recommendations.
  • Identification of equipment and processes needing validation; and development and execution of corresponding validation protocols and reports (including IQ, OQ, and PQ).
  • Writing training material and providing training on new process or equipment modifications.
  • Ensure that processes and equipment used in production and in support of the Quality Management System are developed, validated and maintained in compliance with regulatory and corporate requirements.
  • Provide support for design controls and risk management relative to product development.
  • Driving and providing support to quality processes (nonconformance, corrective actions, change control, audits, etc.)

 

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 manufacturing and operational processes.
  • Works with Operations to select and validate equipment and processes used for production.
  • Works with Engineering, Quality, and Operations to maintain controls over approved/ validated equipment and processes used in production.

 

Education/ Skill Requirements

  • Bachelors degree in engineering or science.
  • Minimum 2 years’ manufacturing engineering experience, including experience with validation of processes and equipment.
  • Experience conducting risk management studies (including FMEAs)
  • Strong communication and technical writing skills.
  • Ability to work effectively in team situations as well as independently.
  • Preferred knowledge of 21CFR 820 or ISO 13485 standards.
  • Preferred experience with NX and other CAM software.