11 days old
2018-05-152018-06-13

Quality Assurance Engineer

Franklin, WI
  • Job Code
    139438
Job Opening - Quality Assurance Engineer - Franklin, WI

Quality Assurance Engineer

job description

Permanent position: Quality Engineer needed for a Medical Device Manufacturer in the Milwaukee area. In this role you will be responsible for product and quality system compliance throughout the product lifecycle. This is a newly created role supporting a variety of new product development projects.

Responsibilities for the Quality Assurance Engineer

  • Supports new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA's, Control Plans, Procedure and Process development
  • Supports investigation and resolution of NCRs and CAPAs.
  • Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.
  • Owner of applicable Quality Systems related NCR/CAPA's.

Requirements for the Quality Assurance Engineer

  • Bachelor's degree in Biology or science arena.
  • Five to ten years experience in Medical Device Industry
  • Mastery knowledge of ISO 13485:2003, FDA 21 CFR Part 820 and Sterilization Principles
  • Experience with Statistical Process Control and Process Validation.

Benefits

  • Comprehensive benefits package available
  • Relocation assistance provided

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Quality Assurance Engineer

Randstad Engineering
Franklin, WI

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Randstad Engineering
Franklin, WI

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