Medical Device Supplier Quality Engineer (Electrical)

Katalyst CRO; Pleasanton (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Senior Supplier Quality Engineer with a strong Electrical background for medical device programs in California. You will partner with US and international suppliers to drive quality from supplier selection through PPAP, CAPA, and continuous improvement.

Responsibilities include leading audits, FAI, IQ/OQ/PQ validations, and managing document control and PLM release processes to ensure compliant, on-time component delivery.

Qualifications

• 5 to 6 years of Medical Device Supplier Quality with electrical background.
• Experience with IPC certifications and PCBA inspections.
• Experience interacting with US and overseas suppliers, including supplier evaluation and onboarding.
• Experience with supplier audits, FAI and component qualification for supplier components.
• Experience with IQ, OQ and PQ process validation.
• Experience handling SCAR, RCA and CAPA.
• Experience with document revision control and PLM release processes.

Skills

Supplier quality management

PCBA inspections

Supplier evaluation & onboarding

Supplier audits

SCAR

RCA

CAPA

IQ/OQ/PQ process validation

PLM document control

Education

IPC certifications

Tools

PLM systems

Job description

Katalyst CRO is seeking a Senior Supplier Quality Engineer with a strong Electrical background for medical device programs in California. You will partner with US and international suppliers to drive quality from supplier selection through PPAP, CAPA, and continuous improvement.

Responsibilities include leading audits, FAI, IQ/OQ/PQ validations, and managing document control and PLM release processes to ensure compliant, on-time component delivery.