Quality Engineer - 258712

Medix™; Baltimore (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

Medix seeks a Quality Engineer for medical devices to own supplier quality activities, manage CAPA investigations, and drive continuous improvement in design transfer and production validation. You will lead SCARs, inspections, supplier audits, and collaboration with Product Development on new launches.

The role requires hands-on IPC knowledge, ISO 13485 / FDA 21 CFR 820 experience, and a proactive ownership mindset to improve yield and reduce lead times.

Qualifications

• 3-5 years of quality engineering experience in medical devices (ISO 13485 / FDA 21 CFR 820).
• Hands-on experience with PCBAs, cable/harness assemblies, and IPC standards (IPC-A-610, IPC/WHMA-A-620).
• Proven track record leading CAPA investigations and supplier quality.
• Bachelor's degree in Engineering or related technical discipline.

Responsibilities

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

Skills

Quality engineering

CAPA investigations

Supplier quality

Gage R&R

IPC standards knowledge

Regulatory compliance

Education

Bachelor's degree in Engineering

Tools

ASQ Z1.4

SPC

Cpk

Job description

• 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.