Quality Inspector IV
About The Position
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.
Requirements
- IPC-A-610 Certification (Required)
- 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 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.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
