More jobs:
Supplier Quality; Remediation Engineer
Job in
Newark, New Castle County, Delaware, 19711, USA
Listed on 2026-02-28
Listing for:
International Association of Plumbing and Mechanical Officials (IAPMO)
Full Time
position Listed on 2026-02-28
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
Supplier Quality (Remediation) Engineer in Newark, Delaware -- 12 months (extension up to 3 years)
Medical Device client addressing an FDA 483 observation is seeking a Supplier Quality Remediation Engineer to perform supplier gap assessments and drive remediation activities to ensure regulatory compliance.
Key Responsibilities- Conduct gap assessments between dFMEA and pFMEA; focus on severity alignment and risk controls.
- Evaluate supplier process capability (cPk) and control effectiveness.
- Review/support IQ, OQ, PQ validations at supplier sites.
- Perform Measurement System Analysis (MSA).
- Lead supplier corrective actions and ensure FDA/ISO compliance.
- Document findings and present remediation plans to stakeholders.
- Bachelor’s in Engineering.
- 5+ years in medical device or regulated manufacturing.
- Strong experience in dFMEA, pFMEA, cPk, IQ/OQ/PQ, MSA.
- Knowledge of FDA regulations, ISO 13485, ISO 14971, and QSR.
- Ability to read drawings/blueprints.
- Strong analytical and communication skills.
- Experience with FDA 483 remediation preferred.
- Knowledge of Minitab is a plus.
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