Quality Engineer II - Medical Devices, NPD & Sustaining

Katalyst CRO; Holdrege (NE); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer II to support new product development and sustaining activities for medical devices. You will apply quality engineering skills from inception through launch, ensuring compliance with design controls and regulatory requirements, and collaborating with quality management, operations, suppliers, and clients.

The role emphasizes applying statistical methods, problem-solving, and process improvement to achieve predictable product quality and continuous

Qualifications

• B.S. degree in Engineering (Industrial, Mechanical) or similar.
• 3+ Years Quality experience including Validation and Quality Engineering responsibilities.
• Demonstrate success with statistical and problem-solving methodologies.
• Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.

Responsibilities

• Support the plant on assigned product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
• Provide critical quality engineering direction to projects with respect to quality engineering tools and principles (root cause analysis, FMEAs, risk mitigation, validation, DOE, measurement systems).
• Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Develops solutions to routine problems of moderate scope.
• Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.

Skills

Statistical analysis

Quality engineering principles

Root cause analysis

Process improvement

Validation

Lean Six Sigma

Education

B.S. in Engineering (Industrial/Mechanical)

Tools

Minitab

MS Word

Excel

MS Project

Job description

Katalyst CRO is seeking a Quality Engineer II to support new product development and sustaining activities for medical devices. You will apply quality engineering skills from inception through launch, ensuring compliance with design controls and regulatory requirements, and collaborating with quality management, operations, suppliers, and clients.

The role emphasizes applying statistical methods, problem-solving, and process improvement to achieve predictable product quality and continuous