Quality Engineer, Sterile Medical Devices (Contract to Perm)

Spryte Medical, LLC.; Bedford (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

Spryte Medical, LLC. is seeking a Quality Engineer located in Bedford, Massachusetts. This role is crucial for ensuring that catheter and console products meet regulatory and quality standards during the design and manufacturing processes.

The ideal candidate will have at least 5 years of experience in sterile disposable device engineering, strong communication skills, and a bachelor’s degree in a relevant field. The position is initially a temporary contract with potential for permanent placement.

Qualifications

• Minimum of 5 years' experience in engineering or development of sterile disposable devices.
• Experience in medical device design assurance and design verification.
• Understanding of ISO standards and regulatory requirements.

Responsibilities

• Ensure compliance with regulatory and quality requirements throughout the product development process.
• Coordinate device complaint investigations and perform quality inspections.
• Support manufacturing operations and lead root cause investigations.

Skills

Sterile disposable devices engineering

Medical device design assurance

Design verification

Risk management

Statistical analysis

Communication skills

Education

Bachelor's degree in science or engineering

Tools

Minitab Statistical Analysis software

Job description

Spryte Medical, LLC. is seeking a Quality Engineer located in Bedford, Massachusetts. This role is crucial for ensuring that catheter and console products meet regulatory and quality standards during the design and manufacturing processes.

The ideal candidate will have at least 5 years of experience in sterile disposable device engineering, strong communication skills, and a bachelor’s degree in a relevant field. The position is initially a temporary contract with potential for permanent placement.