Quality Engineer

About the role

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

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 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.
• Affords assistance with risk management activities including the preparation of the risk management file.
• Collaborates 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.

Qualifications

• 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).
• 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.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Works effectively within a cross functional team.

Skills

• 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.
• ASQ Certified Quality Engineer or similar certification is a plus.
• Works effectively within a cross functional team.

Benefits

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs.

Pay

$95,600 - $116,900

Schedule

The work environment characteristics described here are representative of those an employee encounters while performing 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.