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Quality Engineer

Job Description

​Overview

The successful candidate will be involved in new product development activity withing a dynamic Quality Assurance team of a mid-size medical device company that are revolutionizing healthcare through ground-breaking technologies.

Responsibilities

  • Collaborate with product development teams to establish and implement quality plans for new and existing products.

  • Ensure product development activities adhere to FDA regulations, ISO standards, and other relevant quality and regulatory requirements.

  • Conduct risk assessments and support the development of risk mitigation strategies.

  • Identify opportunities for process improvement and collaborate with cross-functional teams to implement changes including design engineering teams.

  • Maintain accurate and up-to-date documentation of quality processes, procedures, and test results.

 

Qualifications

A BS in Engineering or a related field

A minimum of 3 years’ experience in Quality Assurance

A minimum of 3 years’ experience in the Medical Device Industry

Experience in Process and Production Validation and Statistical Methods

Excellent communication skills and attention to detail