QC Inspector

About the role

This is a high-impact, hands-on quality role in an FDA-regulated, Class III medical device environment. Your expertise will directly support the production of the world's most advanced total artificial heart.

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

Requirements

• IPC-A-610 Certification or IPC-A-620 Certification
• 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

Qualifications

• Experience in a medical device FDA-regulated environment

Skills

• Sharp attention to detail
• Commitment to excellence

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

Pay

The expected salary range for this position based in Huntington Beach, California is $22.00 to $35.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Schedule

N/A

Benefits

• Relocation benefits are not available for this posting