Senior QC Inspector, Medical Electronics (FDA-Regulated)

BiVACOR Inc; Huntington Beach (CA); On-site; USD 30,307 - 48,216; Full time

Benefits offered by this job

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

Job summary

BiVACOR Inc in Huntington Beach, California, is looking for a Quality Inspector to join their groundbreaking team developing a total artificial heart. This hands-on role requires expertise in FDA-regulated production and includes responsibilities like inspecting electronic assemblies and conducting electrical tests.

Candidates should have IPC certifications, experience in medical device environments, and a strong understanding of compliance standards. BiVACOR offers competitive pay, benefits, and a chance to contribute to lifesaving innovation.

Qualifications

• IPC-A-610 Certification or IPC-A-620 Certification is required.
• 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 standards.
• Ability to work overtime and occasional weekends as needed.

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.
• Document inspection results per FDA and ISO 13485 requirements.
• Identify, document, and escalate non-conformances.

Skills

IPC-A-610 Certification

IPC-A-620 Certification

Experience in a medical device FDA-regulated environment

5+ years of Quality Inspection experience

Strong understanding of FDA QSR (21 CFR 820) and ISO 13485

Can-do attitude

Strong teamwork and communication skills

Job description

BiVACOR Inc in Huntington Beach, California, is looking for a Quality Inspector to join their groundbreaking team developing a total artificial heart. This hands-on role requires expertise in FDA-regulated production and includes responsibilities like inspecting electronic assemblies and conducting electrical tests.

Candidates should have IPC certifications, experience in medical device environments, and a strong understanding of compliance standards. BiVACOR offers competitive pay, benefits, and a chance to contribute to lifesaving innovation.