QC Inspector

About the Company

BiVACOR is developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We are a team united by purpose, working on groundbreaking medical innovations.

Responsibilities

• Inspect PCBAs, wire harnesses, and electronic assemblies
• Conduct electrical testing including continuity, insulation resistance, and 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 or IPC-A-620 Certification
• Experience in a medical device FDA-regulated environment
• 5+ years of Quality Inspection experience in electronics or electromechanical fields
• Strong understanding of FDA QSR (21 CFR 820) and ISO 13485
• Experience performing incoming, in-process, and final inspection of electronic components

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