Validation Engineer
: Job Details :


Validation Engineer

Katalyst Healthcares and Life Sciences

Location: Holdrege,NE, USA

Date: 2024-12-06T08:06:41Z

Job Description:
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 Branding project 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.
  • pplies 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 new 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 in order to take a lead role in identifying and documenting continuous improvement projects.
  • pprove 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 Required. (Industrial, Mechanic) Desired
  • 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.
  • Strong understanding of failure analysis, test methods and engineering tolerances.
  • Strong verbal, written and interpersonal skills.
  • Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
  • Six Sigma Certification Desired.
  • SQ CQE
  • Working knowledge of 21CFR820, ISO 13485.
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