Quality Engineer III

Katalyst-Healthcares-; 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

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