Overview
We are seeking Manufacturing/Quality Engineers to support a large-scale remediation initiative within the medical device industry.
This contract role offers the opportunity to work directly on production line processes, ensuring compliance, robustness, and efficiency across a wide variety of products.
You will collaborate closely with cross-functional teams in Manufacturing and Quality Engineering, receiving clear direction and support to help drive remediation deliverables forward.
Responsibilities
Review, assess, and update manufacturing processes, with a focus on risk assessment (PFMEA) and process validation (IQ, OQ, PQ).
Write, review, and approve validation protocols, process characterization reports, Repeat Action Assessments (RAA), and Acceptance Equipment Lists (AELs).
Update, review, and approve Manufacturing Instructions (SGOIs) and MES documents.
Support Device Master Record (DMR) remediation activities, including owning NC/CAPA actions as needed.
Ensure all remediation activities are delivered within defined timelines.
Collaborate daily with Manufacturing Engineers and Quality Engineers to optimize line processes.
What We're Looking For
2+ years of experience in medical device manufacturing, quality, or new product introduction (NPI).
Hands-on experience supporting manufacturing lines in a regulated environment.
Strong background in process validation (IQ, OQ, PQ) and risk assessment (PFMEA).
Familiarity with controlled manufacturing documentation (e.g., SOPs, change control, MES).
CAPA experience is an advantage but not required.
Ideal background: Manufacturing Engineer or Quality Engineer with medical device exposure.
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