Quality Engineer

Katalyst CRO; Laramie (WY); Presencial; USD 1 - 2; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality engineering

CAPA

Root cause analysis

Medical device

Design Assurance

Educación

BS in related field

MS in related field

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. CAPA Primary 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