Now hiring in Dallas, TX.
Job Title: Process Engineer
Reports to: Quality Manager
Posted Date: August 10, 2018
- 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.)
- 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 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.