Quality Engineer

Job Description:

The Quality Engineer is responsible for ensuring the quality and reliability of industrial processes, materials, and products. This role involves planning and conducting quality assurance activities, maintaining process and validation plans, and participating in design teams to ensure compliance with design control processes. The Quality Engineer applies statistical analysis to evaluate and improve processes, assists with risk management activities, and collaborates with suppliers to address quality issues and improvements. This position requires strong technical writing skills, effective communication, and the ability to work within cross-functional teams. The Quality Engineer also prepares reports, presents technical information, and directs quality assurance activities to support the organization’s quality objectives. The Quality Engineer will be required to work on-site five days/week and will report to the Quality Engineering Manager.

Job Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintains process and validation plans.  Writes process and or validation protocols. Plans executes and completes validation activities (IQ, OQ and PQ). 
• 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.
• Develop an understanding of Envista Business System (EBS) processes and tools and utilize in the execution of projects (i.e. Problem-Solving Process (PSP) and Visual Project Management (VPM).
• Any duties or tasks that your Supervisor/Manager assigns.

JOB REQUIREMENTS:

• Bachelor's degree (B.S.) in Engineering or a related field.
• 2 years of experience in quality engineering within highly regulated field.
• FDA Quality System Regulation Part 820 and/or ISO 13485 experience.

SKILLS & QUALIFICATIONS:

• 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 high-paced environment.

PHYSICAL DEMANDS:

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 functio