Role details

This position is now filled

Senior Quality Engineer - Medical Device

Wilmington   •   USD90,000 - USD125,000   •  Permanent

Bullet points

  • Our latest client is a Burlington-based medical diagnostics manufacturer.
  • Senior Quality Engineer position managing incoming inspection onsite.

About Our Client

The Senior Quality Engineer- Medical Device position located in the Wilmington area is with an international medical imaging device provider. This privately held manufacturer is over 15 years old with operations in in Japan, Europe, and North America. Our client's latest product, a cardiovascular diagnostics device, has caused massive recent success.

Job Description

Senior Quality Engineer- Medical Device will:

  • Manage quality system architecture, work processes, and staff (incoming inspection)
  • Provide leadership and direction to incoming inspection and Quality Engineering
  • Maintain the organizational Quality Management System in compliance with ISO 13485 and FDA QSR.
  • Lead Quality Engineering support for manufacturing and product launch/development
  • Responsible for ensuring the quality of products, processes and services
  • Coordinate local corrective and preventive action (CAPA) process.
  • Coordinate local Internal Audits.

The Successful Applicant

The Senior Quality Engineer- Medical Device candidate MUST have:

  • BS Engineering or scientific discipline required.
  • Five (5) years of Quality Engineering experience in the medical device field
  • Must have strong experience with incoming inspection
  • Experience with CAPA's management changes and non-conforming
  • FDA QSR expertise, FDA audit experience

What's on Offer

  • Excellent base salary
  • Strong benefits package
  • Great Quality Leadership role with a growing medical device company
  • Reports to Senior Leadership
  • Multiple direct reports
  • Bonus opportunities