QUALITY ENGINEER II

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

Job Description

As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For New Product Development activities, this person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. For Sustaining Product activities, this person will understand, improve, and control operational processes to realize predictable product flow while satisfying established the client standards of quality.

As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For New Product Development activities, this person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. For Sustaining Product activities, this person will understand, improve, and control operational processes to realize predictable product flow while satisfying established the client standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or the client associates to assure compliance with all the client quality policies, procedures, and practices.

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 Project Pearl with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.


• 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. Make basic procedural updates.


• Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements.


• Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.


• Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.


• Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.


• Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.


• Basic Requirements:


• B.S. degree in Engineering (Industrial, Mechanic) 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.


• Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.


• Preferred Requirements:


• Strong understanding of failure analysis, test methods and engineering tolerances.


• Strong verbal, written and interpersonal skills.


• Six Sigma Certification Desired.


• ASQ CQE


• Working knowledge of 21CFR820, 21CFR210 & 21CFR211 ISO 13485.


• Project Management experience.


• Certified Quality Engineer and Certified Quality Auditor (preferred).