Quality Engineer III: CAPA Champion for Medical Devices

Creative Solutions Services, LLC; Maple Grove (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Quality Engineering leader to establish and maintain quality systems for medical devices, focusing on hepatic artery infusion pump products. This role drives CAPA, root-cause analysis, and post-market surveillance to meet regulatory and customer requirements.

Responsibilities include mentoring teams, implementing robust process controls, and coordinating with contract manufacturers and internal QA teams to ensure product quality across development,

Qualifications

• BS or higher in an engineering discipline with relevant medical device knowledge.
• MS preferred for advanced roles.
• Experience implementing and maintaining quality systems in medical devices.

Responsibilities

• Develops and maintains quality engineering methodologies and practices.
• Leads champion quality initiatives across departments.
• Mentors engineering and technical staff.
• Implements CAPA and process controls for development and manufacturing.
• Supports post-market surveillance and supplier quality activities.

Skills

Quality engineering

CAPA

Root cause analysis

Post-market surveillance

Education

BS in Engineering

MS in Engineering

Job description

Creative Solutions Services, LLC seeks a Quality Engineering leader to establish and maintain quality systems for medical devices, focusing on hepatic artery infusion pump products. This role drives CAPA, root-cause analysis, and post-market surveillance to meet regulatory and customer requirements.

Responsibilities include mentoring teams, implementing robust process controls, and coordinating with contract manufacturers and internal QA teams to ensure product quality across development,