QA Inspector – Medical Devices (Cleanroom, Equity)

Versa Vascular; Santa Cruz (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Equity participation

Comprehensive benefits

Career growth opportunities

Job summary

Versa Vascular is seeking a detail-oriented Quality Assurance Inspector to perform incoming, in-process, and final inspections of implantable devices, delivery systems, and purchased components. You will verify labeling, conduct testing, and review quality records in a fast-paced, onsite setting.

Join a startup environment focused on regulatory compliance and manufacturing quality, with opportunities to influence device history records and continuous improvement initiatives.

Qualifications

• High school diploma or equivalent.
• Minimum three years of experience in quality inspection or related manufacturing quality role; medical device experience preferred.
• Experience working in a cleanroom manufacturing environment.
• Basic understanding of FDA requirements and ISO 13485.
• Ability to prioritize work in a fast-paced environment.
• DHR (Device History Record) review experience is a plus.

Responsibilities

• Perform in-process and final inspections of implantable devices and delivery systems against approved specifications and acceptance criteria.
• Verify product labeling for accuracy, completeness, and traceability.
• Perform specified tests using approved methods and accurately document results.
• Identify, document, and segregate nonconforming product; raise issues for evaluation and disposition by authorized personnel.
• Follow applicable GMP and quality-system procedures and maintain traceability and documentation.

Skills

Metrology

Dimensional measurement

Attention to detail

English proficiency

MS Office

Education

High school diploma or equivalent

Tools

Keyence systems

Microscopes

Calibrated instruments

Hand tools

Job description

Versa Vascular is seeking a detail-oriented Quality Assurance Inspector to perform incoming, in-process, and final inspections of implantable devices, delivery systems, and purchased components. You will verify labeling, conduct testing, and review quality records in a fast-paced, onsite setting.

Join a startup environment focused on regulatory compliance and manufacturing quality, with opportunities to influence device history records and continuous improvement initiatives.