Quality Engineer - Medical Devices & CAPA Leader

Creative Solutions Services, LLC; Tampa (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior Quality Engineer to lead quality initiatives for hepatic artery infusion pump products. You will mentor teams, drive CAPA and root cause analysis, and coordinate with contract manufacturers and internal Quality/Operations/Design groups to meet regulatory requirements.

The role focuses on developing and sustaining quality systems for NPD, manufacturing support, and post‑market surveillance, ensuring robust process controls and continuous

Qualifications

• BS with 5+ years’ experience; MS with 3–4 years’ experience is also acceptable.
• Ability to work independently and take direction as needed.
• Medical device experience required.
• Coordinate with contract manufacturer and internal teams on design changes and CAPA records.
• Focus on quality systems and CAPA for hepatic artery infusion pump and accessories; post‑market surveillance duties.

Responsibilities

• Lead and champion quality initiatives across departments and projects.
• Coach and mentor engineering teams on quality practices and processes.
• Investigate, identify and implement best‑in‑class quality engineering practices.
• Own CAPA programs and drive root cause analysis to resolution.
• Develop and maintain streamlined quality systems supporting manufacturing and post‑market activities.

Skills

Quality engineering

CAPA management

Root cause analysis

Mentoring

Problem solving

Education

BS in Engineering or related field

MS in Engineering (preferred)

Job description

Creative Solutions Services, LLC is seeking a senior Quality Engineer to lead quality initiatives for hepatic artery infusion pump products. You will mentor teams, drive CAPA and root cause analysis, and coordinate with contract manufacturers and internal Quality/Operations/Design groups to meet regulatory requirements.

The role focuses on developing and sustaining quality systems for NPD, manufacturing support, and post‑market surveillance, ensuring robust process controls and continuous