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QUALITY ENGINEER II

Katalyst Healthcares & Life Sciences

Holdrege, NE

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Auditing, Certified Quality Engineer (CQE), Change Control, Code of Federal Regulations, Continuous Improvement, Corporate Policies, Customer Relations, Data Analysis, Documentation, Engineering, Environmental Compliance, Failure Analysis, ISO (International Organization for Standardization), Industrial Engineering, Interpersonal Skills, Lean Six Sigma, Maintain Compliance, Medical Equipment, Microsoft Excel, Microsoft Project, Microsoft Word, Minitab, Needs Assessment, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Analysis, Process Control Engineering, Process Improvement, Product Development, Product Programs, Project/Program Management, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulations, Risk Management, Root Cause Analysis, Six Sigma Certification, Software Testing, Statistics Software, Systems Analysis, United States Department of Energy (DOE), Writing Skills
LOCATION
Holdrege, NE
POSTED
23 days ago
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 analyse 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).

About the Company

K

Katalyst Healthcares & Life Sciences

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