Quality Engineer

Katalyst-Healthcares-; Tampa (FL); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality engineering

CAPA management

Root cause analysis

Mentoring

Problem solving

Educación

BS in Engineering or related field

MS in Engineering (preferred)

Descripción del empleo

Summary

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
• Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist

Roles & Responsibilities

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Requirements

• 5+Years with BS, 3 -4 Years with MS
• Ability to take work direction and work independently
• Medical device experience
• coordination and ownership, communicating with the contract manufacturer and BSC Quality/operations/design teams, supporting design changes activities and supplier corrective records, etc. CAPAPrimary work assignments will be involving supporting our Quality systems and Quality operations for our hepatic artery infusion pump and accessories– authoring post market surveillance report, periodic document reviews,
• experiencePost market surveillance
• Experience owning CAPA
• Root cause analysis experience