QC Inspector

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

Help Us Build the Future of the Human Heart.

At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here.

About the Role

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.

Key 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

What You Bring

• IPC‑A‑610 Certification or 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 teamwork 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.

What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

• 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

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. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.