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Supplier Development Quality Engineer
Job in
Westbrook, Cumberland County, Maine, 04098, USA
Listed on 2026-05-31
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-05-31
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Process Engineer
Job Description & How to Apply Below
Job Title:
Supplier Development Quality Engineer
Location:
Scarborough, ME Duration: 09+ Months
We are actively seeking Supplier Development Quality Engineers to support a leading medical device client within their IVDR (In Vitro Diagnostic Regulation) division. This role offers an excellent opportunity to work on high-impact supplier quality initiatives, regulatory compliance, and continuous improvement projects in a fast-paced, regulated environment.
Key Responsibilities:- Lead supplier selection, qualification, and onboarding activities, ensuring alignment with internal quality standards and regulatory requirements
- Perform supplier evaluations and audits to assess manufacturing capabilities, process controls, and quality system compliance
- Drive material qualification activities, including first article inspection (FAI), incoming inspection planning, and validation of supplier-provided components
- Ensure supplier adherence to FDA regulations, ISO 13485 standards, and IVDR requirements
- Collaborate with cross-functional teams (R&D, Manufacturing, Quality, Regulatory) to ensure seamless supplier integration and product quality
- Support supplier quality system development and improvement, including implementation of best practices, process controls, and risk mitigation strategies
- Investigate supplier-related non-conformances, perform root cause analysis, and implement effective CAPA (Corrective and Preventive Actions)
- Monitor supplier performance using KPIs, scorecards, and quality metrics, and drive continuous improvement initiatives
- Participate in change control processes related to suppliers, materials, and processes
- Ensure proper documentation and compliance with internal procedures, GMP, and regulatory expectations
- Provide technical guidance and support to suppliers for process optimization and quality improvements
- Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field
- 3+ years of experience in Supplier Quality / Quality Engineering within the medical device or regulated industry
- Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and IVDR
- Experience with supplier audits, qualification, and performance management
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