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.
Quality Engineer - 258712 in Baltimore at Medix™
This position is listed as full time and onsite. It was posted 5 days ago.