Site Validation Engineer

Overview

On Site
Full Time

Skills

Reporting
Change Management
Training
Change Control
Regulatory Compliance
Lean Methodology
Data Analysis
Continuous Improvement
Leadership
ISO 9000
Auditing
Manufacturing
Quality Assurance
Quality Management
Medical Devices
Problem Solving
Conflict Resolution
Failure Analysis
Test Methods
Minitab
Microsoft Excel
Six Sigma

Job Details

Responsibilities:
  • Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
  • Develop and maintain the Validation Master Plan and validation tracking schedule.
  • Provide visibility related to all validation activities through tracking and reporting plant metrics.
  • Support and influence change management within the plant: liaison between the core team, program managers, and Global quality.
  • Conduct training relevant to validation process and procedures.
  • pprove protocols and reports for all validation and change control activities to ensure compliance with established procedures.
  • Participate in Global validation team meetings as required.
  • Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
  • Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.
  • Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
  • Build interactive working and strategic relationships between company Holdrege manufacturing, business and corporate quality management and other staff.
  • Perform other duties as assigned by the Team Leader and required to support the needs of the business.
Requirements:
  • B.S. degree in Engineering (Industrial, Mechanic) or similar.
  • 3+ Years of Quality experience including Validation and Quality Engineering responsibilities.
  • Statistical and problem-solving skills.
  • Strong understanding of failure analysis.
  • Experience with Statistical software.
  • Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.
  • Demonstrate success with statistical and problem-solving methodologies.
  • 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.
  • SQ CQE.
  • Working knowledge of 21CFR820.
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