Quality Engineer

Job Description

The Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products.

The Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products by performing the following duties:

• Maintains process and validation plans. Writes process and/or validation protocols. Plans, executes and completes 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 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.

• 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.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• 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 a high-paced environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Working hours and shifts will vary and are dependent upon the work cycles required by business needs.
• The noise level in the work environment is usually quiet in office spaces but moderate to loud in manufacturing areas.
• Due to the nature of product contents, careful handling and compliance to procedure and processes are required.
• Ability to stand and/or sit for long periods of time as required by business needs.
• Occasionally push, pull, lift and/or bend as required by business needs.
• Must be able to lift 10 pounds.

• 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,…