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Quality Engineer
Advion BioSystems

Description:

The Quality Engineer devises and supports the implementation of effective quality assurance, process controls, statistical analyses and metrics that assure products meet or exceed internal quality, customer expectations as well as statutory requirements. Provides primary support for development, application and maintenance of the quality management system. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data. Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility. Applies sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues. Compiles and writes training material and conducts training sessions on quality control activities. Participates in cross functional product care teams to identify and resolve customer problems. Provides quality and compliance input to the project team for project decisions and deliverables. Leads the execution of Quality deliverables such as Risk Management, Design FMEA, Quality Plans, and Field Assessment Plans. Provides quality and statutory guidance as needed to assure country specific compliance to the laws and regulations.

Requirements:

The successful candidate must have a Bachelor's degree in Engineering/Science related area or equivalent experience. Must have 3 to 5 years of experience in a Quality role. ASQ Quality Engineer certification is preferred. New product development process experience is required. Must have strong analytical skills and the ability to effectively communicate to all levels of the company.

 

Advion is an Equal Opportunity Employer.