Quality Engineer - Catheter Devices & ISO 13485

T45 Labs; Santa Clara (CA); On-site; USD 132,000 - 178,000; Full time

Benefits offered by this job

Bonuses

Equity options

Comprehensive benefits package

Job summary

A leading medical device company is seeking a Quality Engineer in Santa Clara, CA. The ideal candidate has at least 5 years of experience in the medical device industry, particularly with catheter devices and ISO 13485. Responsibilities include maintaining quality documentation, ensuring compliance with regulations, and conducting risk assessments. The position offers a competitive salary ranging from $132,000 to $178,000 annually.

Qualifications

• 5+ years of Quality experience in the regulated medical device industry.
• Proven expertise in ISO 13485 implementation and compliance.
• Experience in process optimization and test method development.

Responsibilities

• Develop and maintain Quality System documentation.
• Ensure compliance with FDA regulations and ISO standards.
• Conduct root cause analysis and support CAPA implementation.

Skills

ISO 13485 expertise

Catheter device experience

Documentation development

Process improvement

Risk assessment

Strong organizational skills

Communication skills

Education

Bachelor's degree in Mechanical, Biomedical, or related Engineering discipline

Job description

A leading medical device company is seeking a Quality Engineer in Santa Clara, CA. The ideal candidate has at least 5 years of experience in the medical device industry, particularly with catheter devices and ISO 13485. Responsibilities include maintaining quality documentation, ensuring compliance with regulations, and conducting risk assessments. The position offers a competitive salary ranging from $132,000 to $178,000 annually.