Quality Engineer - 258712

Job Description

Responsibilities

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• Supplier Quality: Own SCARs, supplier audits, first-article inspections (FAI), and technical interfaces with key PCB and cable assembly vendors.
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• Nonconformance & CAPA: Lead investigations to root cause, disposition nonconforming materials, and track corrective actions through effectiveness verification.
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• Applied Statistics: Design risk-based inspection strategies and sampling plans using ANSI/ASQ Z1.4, $C_{pk}$/SPC, and Gage R&R.
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• Process Optimization: Partner with Production on time studies, yield analysis, and defect elimination to boost capacity and reduce lead times.
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• Design Transfer: Establish material controls and perform production validation alongside Product Development for new product launches and revisions.
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Qualifications

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• 3–5 years of Quality Engineering experience in medical devices (ISO 13485 / FDA 21 CFR 820).
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• Electronics & Hardware Literacy: Hands-on experience with PCBAs, cable/harness assemblies, and IPC standards (IPC-A-610, IPC/WHMA-A-620).
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• True Ownership: Proven track record leading CAPA investigations and supplier quality, not just participating in them.
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• Education: Bachelor’s degree in Engineering or a related technical discipline.
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