Quality Engineer

Envista Dentistry•Pomona, CA

15d•Onsite

About The Position

The Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. This role involves maintaining process and validation plans, writing and executing validation protocols, and participating in design teams as a QA representative to ensure design control processes are followed. The Quality Engineer will perform quality engineering reviews of design documentation, apply statistical analysis to evaluate processes, and assist with risk management activities. Collaboration with suppliers to review changes and identify quality issues is also a key responsibility. The role requires developing new approaches to solve problems, communicating significant issues and recommended process improvements to management, and preparing reports on quality assurance activities. Additionally, the Quality Engineer will present technical information and may direct technical and administrative workers engaged in quality assurance activities.

Requirements

Effective interpersonal communication skills and able to interface with cross functional teams.
Strong technical writing skills; able to explain technical terminology in layman’s terms to product development groups, peers and senior management.
Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner.
Adaptable to work with software-based development and automated processes.
Works effectively within a cross functional team.
Excellent oral and written communication skills to support design change documentation, team leadership, project updates, interaction with all levels within the organization and communication with external thought leaders (internal and external).
Strong computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook, and Microsoft Project).
Able to type 50 WPM.
Sound understanding of regulatory and compliance documentation processes, review cycles and information repositories (meeting minutes, templates, charter documentation etc.).
Strong interpersonal skills that create followership and motivate team members.
Driven and motivated individual with demonstrated critical thinking and analytical skills.
Unquestionably high ethical standards and attention to reputational and compliance risks.
Organized thinker that can prioritize tasks in real time and exercise judgment in high-paced environment.
Bachelor's degree (B. S.) in Engineering or a related field from a four-year college or university.
2+ years of QE experience in any regulated industry (Medical devices, Pharma, healthcare preferred)

Nice To Haves

Adaptable to work with software-based development and automated processes.
ASQ Certified Quality Engineer or similar certification is a plus
Effective interpersonal communication skills and able to interface with cross functional teams.
Strong technical writing skills; able to explain technical terminology in layman’s terms to product development groups, peers and senior management
Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner
Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Works effectively within a cross functional team.

Responsibilities

Maintains process and validation plans.
Writes process and or validation protocols.
Plans execute and complete validation activities.
Participates in design teams as a QA representative to ensure design control process is followed.
Performs quality engineering reviews of design documentation for compliance with stated requirements.
Applies principles of statistical analysis to evaluate the current process and process changes.
Assists with risk management activities including the preparation of the risk management file.
Work with our suppliers to review changes and identify any quality issues or improvements.
Develops new approaches to solve problems identified during quality engineering activities.
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
Prepares and presents technical and program information to team members and management.
Directs technical and administrative workers engaged in quality assurance activities.
Any duties or tasks that your Supervisor/Manager assigns.