Quality Engineer - Medical Devices | Lean and CAPA Expert

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 and drive improvements across measurement, inspection, and process controls. You will lead MSAs, GD&T reviews, FMEA, control plans, FAI and DOE input, and provide cross-functional technical support to program management.

Responsibilities include SPC monitoring, first article review, NCRs/CAPA coordination, DMR control, root cause analysis, and collaboration with suppliers and customers to prevent recurrence.

Qualifications

• Bachelor of Science in Engineering or similar technical discipline.
• ASQ CQT or CQE certification is desirable.
• Experience with metrology equipment and SPC.
• Strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Lead new product launches with MSA, GD&T reviews, FMEA, control plans, FAI and DOE input.
• Identify critical variables and attributes and perform first article sampling.
• Conduct statistical analysis and SPC dimensional monitoring for production.
• Prepare validation quotes and provide technical support to Program Management.
• Oversee DMR control for new launches and implement Engineering Change Orders.
• Lead CAPA process and assist ISO 13485 and FDA audits as needed.
• Coordinate root cause analysis, corrective actions, and supplier/customer interfaces.

Skills

Analytical thinking

Problem solving

Team collaboration

Communication

Education

Bachelor of Science in Engineering

ASQ CQT/CQE

Tools

Solidworks

Minitab

Microsoft Office

Job description

SMC Ltd in Santa Rosa, CA, is seeking a Quality Engineer to support the quality system and drive improvements across measurement, inspection, and process controls. You will lead MSAs, GD&T reviews, FMEA, control plans, FAI and DOE input, and provide cross-functional technical support to program management.

Responsibilities include SPC monitoring, first article review, NCRs/CAPA coordination, DMR control, root cause analysis, and collaboration with suppliers and customers to prevent recurrence.