Manufacturing Quality Engineer

Newark, DE - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job 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:

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 t...