What are the responsibilities and job description for the Product Quality Engineer position at Skills Alliance?
🔬 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
What you must have:
- 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