Quality Inspector IV

BiVACOR Inc • Huntington Beach, CA

24d • $28 - $35 • Onsite

About The Position

This is a high-impact, hands-on quality role in an FDA-regulated, Class III medical device environment, where your expertise will directly support the production of one of the most groundbreaking medical innovations of our time. As a key contributor to BiVACOR's manufacturing quality operations, you will bring deep technical knowledge, sharp attention to detail, and a commitment to excellence that helps move us closer to putting the world's first Total Artificial Heart in the hands of patients who need it most.

Requirements

• IPC-A-610 Certification (Required)
• 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.

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

Benefits

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 11-50 employees