Quality Engineer

About the Role

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

Responsibilities

• 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 the 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.
• Works with suppliers to review changes and identify 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.
• Performs any duties or tasks assigned by a Supervisor/Manager.

Qualifications & Skills

• Effective interpersonal communication skills and ability 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.
• Critical thinking skills and ability to be assertive & challenge the process diplomatically.
• Adaptable to work with software-based development and automated processes.
• Excellent oral and written communication skills to support design change documentation, team leadership, project updates, and interaction with all levels within the organization and external thought leaders.
• Strong computer 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 who can prioritize tasks in real time and exercise judgment in a high-paced environment.

Physical Demands

• Working hours and shifts vary and are dependent upon 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 with procedures and processes are required.
• Ability to stand and/or sit for long periods as required by business needs.
• Occasionally push, pull, lift, and/or bend as required by business needs.
• Must be able to lift 10 pounds.