• Quality Inspector IV within medical device industry - FDA exposure needed
• Be part of the journey of this world-first Total Artificial Heart development
• Huntington Beach, CA
• $28 – $34 per hour + benefits
• Full-Time | Non-Exempt

BiVACOR is seeking an experienced Quality Inspector IV to support our growing medical device manufacturing operations in Huntington Beach.

This is a hands-on inspection role in an FDA-regulated, Class III medical device environment.

What you need to be successful:

• IPC-A-610 Certification (highly desired)
• IPC-A-620 Certification (highly desired)
• Experience in a medical device FDA-regulated environment
• 5+ years of Quality Inspection experience (electronics or electromechanical)
• Strong understanding of FDA QSR (21 CFR 820) and ISO 13485
• Can-do attitude - big picture thinking - strong team work and communication
• Willingness to work overtime and occasional weekends as needed to support BiVACOR as we grow
• Perform incoming, in-process, and final inspection of electronic and electromechanical components in an FDA-regulated medical device manufacturing environment.

Key Responsibilities:

• Inspect PCBAs, wire harnesses, and electronic assemblies
• Conduct electrical testing (continuity, insulation resistance, Hi-Pot)
• Verify compliance with IPC-A-610 and IPC-A-620 standards
• Review work against engineering drawings and specifications
• Document inspection results in accordance with FDA and ISO 13485 requirements
• Identify, document, and escalate non-conformances
• Support continuous improvement within Quality and Manufacturing

Ideal Background:

• Class II or III medical device experience
• Strong electronics manufacturing inspection background
• Experience with PCBAs, wire harnesses, and electronic assemblies
• Comfortable working in a fast-paced, evolving production environment

Education is not strictly required; relevant technical experience is valued.

Growth Opportunity

As production scales, the Quality team will expand. This role offers future progression opportunities within Quality as operations grow.