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M
Medix™
Quality Engineer - 258712
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Job Description
Quality Engineer - 258712 at Medix Quality Engineer - 258712 at Medix in Halethorpe, Maryland Posted in 16 days ago.
Type:
full-time
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.
Benefits
- Dental Insurance