Quality Engineer

Engineering Sumter, South Carolina


Description

Job Summary

The Quality Engineer provides quality-related oversite of the site facilities and engineering programs including systems commissioning and qualifications, preventative maintenance activities, and technical change control. This role is also engaged in the design, development, and coordination of Quality Improvement (QI) and Performance Improvement (PI) initiatives in support of superior quality and operational outcomes at the Company.

 

Duties and Responsibilities

  • Provide quality-related oversite of facility projects, including installation and upgrading of equipment, to ensure site is maintained in a qualified state of operation.
  • Act a Quality point of contact for all site qualification and validation activities including the review and approval of lifecycle documents such as IQ/OQ/PQ and validations.
  • Review requirement specifications and technical documents and provide timely and meaningful feedback.
  • Oversee the site’s Technical Change Control for facilities and equipment changes.
  • Lead the development and implementation of site qualification and validation processes in compliance with CFR 111.
  • Collaborate on design, development, and coordination of QI and PI initiatives. Interface with internal project teams and stakeholders.
  • Effectively communicate relevant project information to the Leadership Team.
  • Drive a systematic approach to problem solving and process improvement using quality management and engineering tools such as Six Sigma, DMAIC, Statistical Process Control, Design of Experiment, etc.
  • Evaluate quality results, trend analyses and reviews of validation, procedures, deviations, out-of-specification results, corrective and preventive actions.
  • Lead cross-functional project teams to implement systems which reduce quality defects and improve customer satisfaction.
  • Create detailed, comprehensive and well-structured test plans and test cases.
  • Estimate, prioritize, plan and coordinate testing activities.
  • Identify, record, document and track non-conformity issues.
  • Manage nonconformity issues and support the development and implementation of solutions.

 

Required Qualifications

  • Bachelor’s degree in technical area (preferably Food Safety, Engineering or Science).
  • 8 years’ experience in Quality Engineering, Control or Assurance in the nutraceutical, pharmaceutical, food or medical device industry.
  • 5 years’ project management/leadership experience.
  • 5 years’ experience in systems qualification/validation.
  • 3 years’ experience with Six Sigma, QC/QA methodologies, tools, and processes.
  • 3 years’ experience working with FDA Regulations.
  • Strong communication, organizational, teamwork, presentation, analytical, reporting and project management skills.
  • Thorough understanding of performance improvement skills and techniques.
  • Knowledge of statistical principles and analysis and failure investigation principles.
  • Proficiency in Microsoft Office including Excel, Outlook, and PowerPoint.

 

Preferred Qualifications

  • ASQ, PMP or lean certification.

 

Physical Requirements

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.