Product Quality Engineer
Listed on 2026-05-31
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Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Product Quality Engineer (Sterilization) | Class III Medical Devices New Jersey (On-site) | Competitive Salary + Bonus
This is an entry-level hands‑on quality engineering hire with a commercial stage organ technology company pioneering normothermic machine perfusion technology used in transplantation worldwide. Reporting into the Senior Manager, Product Quality Engineering, you will play a key role in monitoring and improving the performance of a Class III medical device that has already supported thousands of transplants globally.
Working closely with Product Sustaining Engineering, contracted suppliers, and cross‑functional engineering teams, you will lead hands‑on investigations of returned product and contribute to quality processes spanning sterilization, microbiology, supplier management, and contract manufacturing.
What you will own:- Hands‑on complaint investigations and root cause analysis of returned product
- Full decontamination of returned product per established procedures
- Lab work including monitoring test circuits and preparing equipment for evaluation
- Development of investigation criteria and test methods to diagnose field failures
- Raising Supplier Corrective Action Reports (SCARs) and supporting their closure
- Supporting CAPAs, escalations, and engineering investigations in response to field quality issues
- DHR, Service History, and PFMEA reviews in support of complaint investigations
- Cross‑functional collaboration to implement manufacturing and inspection changes
- Bachelor's degree in an Engineering discipline (Electrical, Mechanical, Bio‑Medical, or equivalent)
- 0-2 years of hands‑on engineering experience in Medical Devices, Pharmaceuticals, or another regulated industry
- Familiarity with quality engineering principles including complaint investigation, SCARs, and CAPAs
- Excellent technical report writing skills and strong MS Office proficiency
- Strong attention to detail and a "do it right the first time" mindset
- Prior complaint investigation or hands‑on lab experience preferred
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