Quality Engineer - 258712
medixtmBaltimore (MD)
About the role
Responsibilities:
Supplier Quality: Own SCARs, supplier audits, first-article inspections (FAI), and technical interfaces with key PCB and cable assembly vendors. Nonconformance & CAPA: Lead investigations to root cause, disposition nonconforming materials, and track corrective actions through effectiveness verification. Applied Statistics: Design risk-based inspection strategies and sampling plans using ANSI/ASQ Z1.4, $C_{pk}$/SPC, and Gage R&R.Process Optimization: Partner with Production on time studies, yield analysis, and defect elimination to boost capacity and reduce lead times. Design Transfer: Establish material controls and perform production validation alongside Product Development for new product launches and revisions.
Qualifications:
3–5 years of Quality Engineering experience in medical devices (ISO 13485 / FDA 21 CFR 820).Electronics & Hardware Literacy: Hands-on experience with PCBAs, cable/harness assemblies, and IPC standards (IPC-A-610, IPC/WHMA-A-620).True Ownership: Proven track record leading CAPA investigations and supplier quality, not just participating in them.
Education: Bachelor’s degree in Engineering or a related technical discipline.
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