Quality Engineer

Katalyst-Healthcares-; Laramie (WY); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

Creative Solutions Services, LLC is seeking a senior Quality Engineering leader to advance the quality systems for medical devices, including CAPA, post-market surveillance, and design changes coordination with contract manufacturers.

You will mentor cross-functional teams, drive root-cause analysis, and implement robust process controls to meet regulatory requirements and customer expectations across hepatic artery infusion pump products and accessories.

Formación

• Minimum 5 years of experience with a BS; 3–4 years with an MS.
• Medical device experience is required.
• Experience owning CAPA and performing root cause analysis.
• Coordination with contract manufacturers and cross-functional teams.
• Knowledge of post-market surveillance and regulatory requirements.

Responsabilidades

• Provides leadership on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical personnel.
• Proactively investigates and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance in identifying and resolving quality issues.
• Identifies and implements effective process control systems to support development, qualification, and manufacturing.

Conocimientos

Quality leadership

CAPA management

Root cause analysis

Regulatory compliance

Medical device experience

Educación

BS in Engineering

MS in Engineering

Herramientas

CAPA software

QMS software

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