Senior Supplier Quality Engineer - Medical Devices

Katalyst CRO; Murrysville (Westmoreland County); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Supplier Quality Specialist in the United States to drive supplier quality initiatives, new product implementation and validation activities. You will partner with engineering, manufacturing and procurement to ensure process compliance and successful product launches.

The role requires a Bachelor's in engineering and 5+ years in supplier quality within regulated environments, with strong APQP, PFMEA, MSA and SPC expertise.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 5+ years in Supplier Quality/Quality Engineering within a regulated industry.
• Strong knowledge of APQP, PFMEA, Control Plans, MSA, SPC and process validation.

Responsibilities

• Collaborate with engineering, manufacturing, procurement and supplier partners to define quality requirements and mitigate risks.
• Support supplier qualification, onboarding, and quality planning for new and existing products.
• Review quality documents including PFMEA, Control Plans, Process Flows, MSA and validation protocols.
• Coordinate supplier audits, performance evaluations and continuous improvement initiatives.
• Investigate supplier quality concerns using CAPA/SCAR and root cause analysis.
• Support transfers, engineering changes and NPI activities while ensuring quality compliance.
• Assist with IQ/OQ/PQ, equipment qualifications and production readiness.

Skills

APQP

PFMEA

Control Plans

MSA

SPC

Process Validation

Cross-functional Collaboration

Analytical Skills

Education

Bachelor's degree in Engineering

Tools

CAPA system

SCAR

Nonconformance investigations

Quality systems

Job description

Katalyst CRO is seeking a Supplier Quality Specialist in the United States to drive supplier quality initiatives, new product implementation and validation activities. You will partner with engineering, manufacturing and procurement to ensure process compliance and successful product launches.

The role requires a Bachelor's in engineering and 5+ years in supplier quality within regulated environments, with strong APQP, PFMEA, MSA and SPC expertise.