Quality Engineering Lead - Medical Devices & CAPA

Creative Solutions Services, LLC; Arlington (VA); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior quality engineering professional to develop and maintain company quality methodologies and systems in support of hepatic artery infusion pump products and accessories. You will serve as a Quality representative, champion cross-functional initiatives, and mentor engineering teams to ensure compliance with regulatory and customer requirements.

Responsibilities include leading CAPA activities, driving process improvements, and coordinating with

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.

Job description

Creative Solutions Services, LLC is seeking a senior quality engineering professional to develop and maintain company quality methodologies and systems in support of hepatic artery infusion pump products and accessories. You will serve as a Quality representative, champion cross-functional initiatives, and mentor engineering teams to ensure compliance with regulatory and customer requirements.

Responsibilities include leading CAPA activities, driving process improvements, and coordinating with