More jobs:
Supplier Quality Engineer
Job in
Lewes, Sussex County, Delaware, 19958, USA
Listed on 2026-02-14
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-02-14
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Process Engineer
Job Description & How to Apply Below
We are seeking an experienced Supplier Quality Engineer to ensure supplier compliance with FDA, GMP, and global quality standards. The role focuses on supplier qualification, performance monitoring, and quality issue resolution to support uninterrupted manufacturing operations.
Key Responsibilities- Qualify, audit, and manage suppliers in compliance with GMP, FDA, ISO 13485, and ICH guidelines
- Lead supplier audits, risk assessments, and supplier performance evaluations
- Review and approve supplier quality documentation (PPAPs, change controls, deviations, CAPAs)
- Investigate supplier-related quality issues and drive root cause analysis and corrective actions
- Collaborate with Procurement, Manufacturing, and Quality teams to ensure material compliance
- Support regulatory inspections and internal audits related to supplier quality
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5+ years of Supplier Quality experience in pharmaceutical or medical device industry
- Strong knowledge of GMP, FDA regulations, and supplier audit processes
- Experience with CAPA, deviations, risk management, and change control
- Excellent communication and cross‑functional collaboration skills
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