Manufacturing Quality Engineer - Newark, DE

Newark, DE, US β€’ Posted 5 hours ago β€’ Updated 1 hour ago
Contract W2
On-site
Fitment

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Job Details

Skills

  • Manufacturing
  • IQ/OQ/PQ
  • Risk Analysis
  • Biomedical Engineering
  • Corrective and Preventive Action
  • Research Skills
  • Failure Mode Effects Analysis
  • Manufacturing Quality
  • Programme Management
  • Failure Causes

Summary

Title : Manufacturing Quality Engineer
Location : Newark, DE
Long-term contract
Overview

We are partnering with a leading medical device organization to build out a high-impact engineering team supporting their flagship mammography systems. This is a critical initiative focused on strengthening the foundation of their Quality Management System and driving validation excellence across manufacturing operations.

Must-Have Background

  • 4 5+ years medical device experience (minimum)
  • Engineering degree required (Mechanical, Biomedical, Industrial, etc.)
  • Experience at established med device companies (e.g., Stryker, J&J, etc.)
  • Prior remediation experience strongly preferred
  • Strong validation and TMV experience

Day to Day

  • Review and enhance existing PFMEAs, Identify missing failure modes and risk gaps, strengthen mitigations and ensure appropriate controls are in place (PFMEA assessment, development, and remediation).
  • Conduct thorough process risk analysis, drive root cause investigations and implement corrective actions.
  • Lead and execute validation activities (IQ/OQ/PQ), develop and defend validation strategy and protocols, execute and document TMV activities
  • Manage deviations, link risks appropriately, and ensure regulatory alignment
  • Collaborate cross-functionally with manufacturing, quality, and program management stakeholders


    Usha M

    Sr. Pharma/Medical Recruiter

    Email:

Employers have access to artificial intelligence language tools (β€œAI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91090330
  • Position Id: 2026-3533
  • Posted 5 hours ago
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