Role details

NPD Quality Engineer - ISO 13485

Springfield   •   USD75,000 - USD90,000   •  Permanent

Bullet points

  • Requirements: NPD, validation, ISO 13485, design control
  • BS in Engineering required

About Our Client

Our client is a medical device company with expertise in working with start-up companies to design and produce products and bring them to market. This organization is fast growing and well established with a strong emphasis on employee satisfaction.

Job Description

The NPD Quality Engineer - ISO 13485 will be responsible for:

  • Leading complex projects
  • Provide Quality Engineering support for engineering project development.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.



The Successful Applicant

The NPD Quality Engineer - ISO 13485 requirements include:

  • BS in Engineering
  • NPD and/or start-up experience
  • Process validation, IQ/OQ/PQ
  • Design Control highly preferred
  • Sterilization experience highly preferred

What's on Offer

  • Great team culture with emphasis on employee satisfaction
  • Competitive compensation package
  • Profit sharing
  • Dynamic projects and work load

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1199758
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