Quality Inspector
BiVACOR
Quality Assurance
Huntington Beach, CA, USA
Posted on Mar 20, 2026
- 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.