Quality Engineer
Job in
Lexington, Middlesex County, Massachusetts, 02421, USA
Listed on 2026-08-15
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-08-15
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Biomedical Engineer, Manufacturing Engineer
Job Description & How to Apply Below
Quality Engineer
This role will be responsible for ensuring the new catheter and console products and design changes to existing products meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process. This will be accomplished through close collaboration with cross-functional teams. The Quality Engineer participates in all phases of the product development process. This includes development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development activities, product risk management requirements, and delivery.
Requirements:
- Medical Device industry.
- 3+ years of experience.
- Complaint investigations.
- CAPA's.
- Evaluating nonconforming material.
- Experience with catheters or sterile disposables.
- Process Validation, IQ/OQ/PQ.
- Design Control.
- Risk Analysis.
- FMEA.
- Sustaining engineering.
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