Quality Engineer

Katalyst CRO; Cheyenne (WY); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies that meet medical device requirements, while serving as a Quality representative across development, manufacturing, and supplier interfaces. This role is based in Cheyenne, WY and involves leading cross-functional quality initiatives.

You will lead CAPA, conduct root cause analyses, drive post-market surveillance activities, and mentor technical staff, collaborating with contract

Qualifications

• BS degree in a related field; MS preferred for advanced roles.
• 5+ years of quality engineering experience; medical device background
• Experience owning CAPA and post-market surveillance activities
• Proven root cause analysis and problem-solving skills
• Ability to lead cross-functional teams and mentor staff

Responsibilities

• Lead quality initiatives across development and manufacturing to meet regulatory requirements.
• Drive CAPA programs, root cause analysis, and corrective actions.
• Oversee post-market surveillance and ongoing quality system improvements.
• Collaborate with contract manufacturers and internal design teams on quality changes.
• Mentor engineers and provide technical guidance on quality practices.

Skills

Quality engineering

CAPA

Root cause analysis

Post-market surveillance

Leadership

Independent work

Coordination with manufacturers

Design changes support

Education

BS in a relevant field

MS preferred

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