Quality Engineer
jobdivaLexington, MA
Quality Engineer
jobdivaLexington, MA
4 days ago
Industries
Surgical and Medical Instrument ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingSurgical Appliance and Supplies ManufacturingAbout the role
Responsibilities:
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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JOB OVERVIEW
Experience level
Lead
Location
Lexington, MA
Occupation
Validation Engineers
Industry
Surgical and Medical Instrument Manufacturing
Posted
4 days ago
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