Quality Engineer – Medical Devices & Lean Launches

SMC Ltd.; Santa Rosa (CA); On-site; USD 75,000 - 100,000; Full time

Job summary

SMC Ltd. in Santa Rosa, CA, is seeking a Quality Engineer to support the quality system, drive improvements in measurement, supplier quality, and problem resolution.

You will lead new product launches with MSA, GD&T, FMEA, control plans, FAI and DOE input, and provide production support for inspection methods and data analysis. This role also involves CAPA, internal and FDA audits, and Lean projects to continually improve processes and product quality.

Qualifications

• BS in Engineering or related technical field preferred.
• Excellent planning, leadership, and client relations skills.
• Strong written and spoken communication skills.
• ASQ, CQT/CQE certifications preferred.
• SolidWorks modelling experience.
• Experience with metrology equipment, MS Office, and SPC.

Responsibilities

• Lead new product launches with MSA, GD&T reviews, FMEA, control plans, FAI and DOE input.
• Identify critical variables and attributes.
• Perform first article sampling and reporting.
• Conduct statistical analysis as needed.
• Monitor SPC for production quality.

Skills

Leadership

Planning

Client relations

Communication

ASQ

Geometric GD&T

Education

Bachelor of Science in Engineering

ASQ/CQT/CQE

Tools

SolidWorks

Minitab

MS Office

Job description

SMC Ltd. in Santa Rosa, CA, is seeking a Quality Engineer to support the quality system, drive improvements in measurement, supplier quality, and problem resolution.

You will lead new product launches with MSA, GD&T, FMEA, control plans, FAI and DOE input, and provide production support for inspection methods and data analysis. This role also involves CAPA, internal and FDA audits, and Lean projects to continually improve processes and product quality.