Quality Engineer III

Katalyst CRO; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Maple Grove, MN, seeks a senior Quality Engineering leader to drive quality methodologies and CAPA programs across development, operations, and supplier networks. You will mentor teams, champion quality initiatives, and ensure compliance with regulatory and customer requirements for medical devices.

Responsibilities include leading cross-functional quality projects, implementing process controls, and advancing post-market surveillance activities while aligning with corporate

Qualifications

• 5+ years experience with BS; 3-4 years with MS.
• Medical device experience.
• CAPA ownership and post-market surveillance.
• Root cause analysis experience.
• Coordination with contract manufacturers and internal teams.
• Ability to work independently.
• Quality systems and CAPA processes.

Responsibilities

• Leads quality engineering initiatives across departments and functions.
• Provides direction, coaching, and mentoring for engineering staff.
• Identifies and implements best-in-class Quality Engineering practices.
• Supports design changes activities and supplier corrective records.
• Authoring post market surveillance reports and periodic reviews.

Skills

CAPA ownership

Root cause analysis

Medical device experience

Coordination and communication with供应?

Education

Bachelor's degree

Master's degree

Job description

• 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


• 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.

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