Quality Engineer II

Katalyst CRO; Holdrege (NE); On-site; USD 70,000 - 95,000; Full time

Job summary

Katalyst CRO in Holdrege, Nebraska is seeking a Quality Engineer II to support new product development and sustaining activities for medical devices, applying quality engineering tools to ensure design controls, regulatory compliance, and robust processes.

You will collaborate with quality management, operations, suppliers, and clients, lead risk analysis, validation, DOE, and control plans, and drive continuous improvement through Lean and Six Sigma methodologies.

Qualifications

• BS degree in Engineering (Industrial, Mechanical) or similar.
• 3+ years quality experience including validation and QA responsibilities.
• Strong knowledge of quality engineering principles for medical devices.
• Proficient with statistical software and MS Office.

Responsibilities

• Support product initiatives with technical quality engineering expertise.
• Provide QA direction for validation, risk assessment, and change control.
• Apply statistical and problem-solving methods to improve processes.
• Ensure compliance with design controls and regulatory requirements.
• Collaborate with operations, suppliers, and clients to drive continuous improvement.
• Approve protocols and reports for validation activities.

Skills

Root cause analysis

FMEA

DOE

Measurement systems analysis

Lean Six Sigma

Education

BS in Engineering (Industrial/Mechanical)

Tools

Minitab

MS Word

Excel

MS Project

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 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.

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).