Quality Engineer – Medical Devices & CAPA Lead

Katalyst CRO; Tampa (FL); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer to develop and maintain quality engineering methodologies and practices across product development and manufacturing. The role acts as a quality representative to drive awareness and alignment with quality goals at multiple organizational levels.

The candidate will lead cross-functional quality initiatives, mentor engineers, and implement CAPA and process controls to ensure compliance with regulatory requirements and customer expectations.

Qualifications

• 5+ years with BS in a related field; 3–4 years with MS.
• Medical device experience is required or preferred.
• Coordination with contract manufacturers and cross-functional teams.
• Experience owning CAPA and post‑market surveillance activities.

Responsibilities

• Develops, establishes and maintains quality engineering methodologies, systems, and practices.
• Provides leadership to champion departmental or cross‑functional engineering initiatives.
• Mentors engineering staff and supports design changes and supplier quality activities.
• Leads investigation of quality issues using systematic problem solving.
• Implements process controls and CAPA systems to meet internal and external requirements.
• Supports quality operations for devices including hepatic artery infusion pump and accessories.

Skills

Quality engineering

Design Assurance

Operations Quality

Software Engineering

CAPA

Root cause analysis

Education

Bachelor's degree

Master's degree

Job description

Katalyst CRO is seeking a Quality Engineer to develop and maintain quality engineering methodologies and practices across product development and manufacturing. The role acts as a quality representative to drive awareness and alignment with quality goals at multiple organizational levels.

The candidate will lead cross-functional quality initiatives, mentor engineers, and implement CAPA and process controls to ensure compliance with regulatory requirements and customer expectations.