QC Inspector

The role

This person will perform quality inspection for PCBAs, wire harnesses, and electronic assemblies. The role supports manufacturing quality operations in an FDA-regulated, Class III medical device environment.

What you will do

• 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

Required qualifications

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

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

About the company

BiVACOR is developing the world's most advanced total artificial heart. They are an equal opportunity employer.