Quality Engineer, Medical Devices — CAPA & Process Controls

Katalyst CRO; Laramie (WY); On-site; USD 1 - 2; Full time

Job summary

Katalyst CRO in Wyoming seeks a senior Quality Engineer to develop and maintain quality methodologies for medical devices. The role leads cross-functional initiatives, mentors teams, and ensures CAPA and post-market surveillance activities meet regulatory expectations.

Responsibilities include root cause analysis, implementing process controls, coordinating with suppliers, and sustaining quality systems for hepatic artery infusion pump products and related accessories.

Qualifications

• Requires BS with 5+ years, or MS with 3-4 years of experience.
• Medical device experience is required.
• Coordination with contract manufacturers and cross-functional teams for CAPA and post-market surveillance activities.

Responsibilities

• Lead departmental or cross-functional engineering initiatives.
• Mentor technical team personnel and coach project directions.
• Identify and implement best-in-class quality engineering practices.
• Own CAPA processes and root cause analyses to resolve quality issues.
• Support design changes activities and supplier corrective actions.

Skills

Quality engineering

CAPA

Root cause analysis

Medical device

Design Assurance

Education

BS in related field

MS in related field

Job description

Katalyst CRO in Wyoming seeks a senior Quality Engineer to develop and maintain quality methodologies for medical devices. The role leads cross-functional initiatives, mentors teams, and ensures CAPA and post-market surveillance activities meet regulatory expectations.

Responsibilities include root cause analysis, implementing process controls, coordinating with suppliers, and sustaining quality systems for hepatic artery infusion pump products and related accessories.