More jobs:
NPD Quality Engineer
Job in
Cincinnati, Hamilton County, Ohio, 45208, USA
Listed on 2026-02-11
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-02-11
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
One of your clients is seeking an experienced NPD (New Product Development) Quality Engineer to support quality activities throughout the product development lifecycle. This role will partner closely with R&D, Manufacturing, Regulatory, and Operations teams to ensure new products are developed and transferred in compliance with the quality system and regulatory requirements.
The ideal candidate will provide quality oversight for design controls, risk management, validation, and product launches within a regulated life sciences environment.
Key Responsibilities- Provide quality engineering support for New Product Development (NPD) initiatives
- Ensure compliance with design controls and product development processes
- Support risk management activities (FMEA, hazard analysis)
- Review and approve design documentation, including DHF, DMR, and technical files
- Support verification, validation, and design transfer activities
- Partner with cross-functional teams during product development and commercialization
- Ensure compliance with FDA, GMP, ISO 13485, and internal quality standards
- Support audits, inspections, and continuous improvement initiatives
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field
- 5+ years of experience in a Quality Engineering role
- Strong experience supporting NPD / R&D programs
- Experience in medical device or pharmaceutical environments preferred
- Hands‑on experience with design controls, risk management, and validation
- Familiarity with change control and design transfer processes
- New Product Development (NPD) Quality
- Design Controls & Design History File (DHF)
- Verification & Validation
- FDA, GMP, ISO 13485 compliance
- Strong Communication and cross‑functional collaboration
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