QC Inspector
$45,760–$72,800 year
On-siteHuntington Beach, California, United States
Job Summary
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; IPC-A-610/IPC-A-620 certification required; 5+ years of quality inspection experience in a medical device FDA-regulated environment; strong understanding of FDA QSR and ISO 13485; willingness to work overtime and occasional weekends.
Required Qualifications
- IPC-A-610 Certification or IPC-A-620 Certification (Required)
- 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
- Experience performing incoming, in-process, and final inspection of electronic and electromechanical components in an FDA-regulated medical device manufacturing environment.
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