About this opportunity
Medix™ lists this Quality Engineer - 258712 opportunity in baltimore, Maryland. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Worksite address
baltimore, MD, 21276, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.