Role details

Senior Quality Engineer - Medical Device

Marlborough   •   USD100,000 - USD130,000   •  Permanent

Bullet points

  • Excellent Senior Engineer opportunity with a top rated medical device provider.
  • An exciting chance to join an innovative manufacturer on the rise.

About Our Client

The Senior Quality Engineer - Medical Device is with a rising medical device manufacturer which has grown significantly since its birth in the early 2000's. The healthcare manufacturer is headquartered in Europe with production in the United States. The Marlborough-based company has doubled its size in the past five years, comprising of elite scientists, engineers, and other bright minds. Due to favorable reviews of the existing product, this company has raised millions in investment funding.

Job Description

As an integral development team member, the Senior Quality Engineer will be an active participant in, and in some cases lead Test Plan reviews with others in R&D. He/she will provide recommendations to others in Quality and to the development teams as needed; especially to junior members of the Quality group.

Functions:

  • Implementing, reviewing and creating validation/verification, both for Quality and the development teams
  • Identifying, reporting, and following up on test failures and observed defects
  • Work with the product development teams to isolate failure modes and capture methods to reproduce product problems
  • Reviewing and creating new/enhanced product requirements to ensure that the products are testable and meet both written and implied requirements.
  • Drive Quality Systems, prepare for FDA audits, 510 (k) submissions

The Successful Applicant

Requirements:

  • BS Engineering required
  • 8-10 years of Quality, Validation or Manufacturing Engineering in a regulated field required, medical device preferred
  • Strong validation and verification working experience

What's on Offer

Offer:

  • Great base salary
  • Strong benefits package
  • Stock options
  • Great well-rounded Quality Engineer role with exposure to multiple functions
  • Bonus potential

Apply for this job

Click the Apply or LinkedIn button below or contact Daniel Ferzoco quoting job reference 1198385
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