Role details

Project Quality Engineer - Medical Device

Boston   •   USD70,000 - USD90,000   •  Permanent

Bullet points

  • Project Quality Engineer in Boston with a medical device parts provider.
  • Injection molding, project and Quality Engineering experience is needed.

About Our Client

Our client is a global industrial manufacturer with 35,000 employees in over 55 countries. The publicly-held company is a leading provider in a number of industries including consumer products, telecommunications, aerospace, materials, medical device, and automotive. This site, located in the Boston area, is part of the organization's medical and healthcare division. The FDA registered site manufactures parts and components for devices such as catheters, surgical devices, specialty needles, and hypotubes.

Job Description

The a Project Quality Engineer - Medical Device will contribute to program performance, verification of product/process conformance and customer satisfaction by providing technical expertise and leadership for executing product assurance engineering activities throughout the project lifecycle. Other responsibilities include:

  • Implementation, maintenance, and validation of the Quality Management System in the Boston area site for assigned customer to assure company and contractual quality requirements are satisfied.
  • Participate in the development of new projects from quotation support, through development and validation of molds, equipment, and manufacturing processes, and successful transfer to Manufacturing.
  • Review product design for compliance with engineering principles, engineering standards and customer requirements and specifications.
  • Ensure that mold, process, or assembly testing is performed in a manner that will give us a thorough development, and a robust manufacturing process.
  • Determine test and DOE objectives.
  • Write and review reports as related to the project including validation reports and summaries.

The Successful Applicant

The Project Quality Engineer - Medical Device located in the Boston area MUST have:

  • Bachelor of Science in Engineering is required!
  • Minimum two (2) years of tooling, project, or quality engineering in medical device manufacturing
  • Strong knowledge and experience with plastics and injection molding processes
  • ISO13485 and FDA knowledge and experience
  • Strong validation experience, IQ OQ PQ protocols
  • MUST be local!

What's on Offer

Offer:

  • Excellent opportunity for development with a global organization
  • Fantastic training from international managers
  • Competitive base salary for a mid-level position
  • Great benefits package

Apply for this job

Click the Apply or LinkedIn button below or contact Daniel Ferzoco quoting job reference 1194727
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