Covington Georgia / United States

Roles and Responsibilities:-

• Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
  
• Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
  
• Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
  
• Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
  Capable of using Microsoft programs and ability to learn other systems.
  
• Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management.
  May require consultation and direction to complete the essential duties and responsibilities.
  
• Understands basic applied statistics.
  
• Knowledge of manufacturing processes
• Comprehensive knowledge of quality systems and relationship to business.
  
• Ability to participate on teams and maintain positive work environment with those teams.
  
• Understands Basic Fundamentals of Engineering Principles
• Ability to translate quality requirements into product specifications.
  
• Ability to interpret Regulations, Corporate, Division and Department Procedures.
  
• The ability to work in teams and independently with minimal supervision to obtain results as required.
  

Education and Experience:-

• BS or BA in related field required with 4 years of experience, or MS with 3 years of experience required (project management experience preferred).
  
• Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
  
• Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.
  e.
  : Good Manufacturing Practices, ISO, FDA).
  
• Professional certification is an advantage (i.
  e.
  CQA, CQE, SQE, CQM, Six Sigma, etc.
  ).
  
• Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
  

Skills:-

• Effective verbal and written communication skills.
  
• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
  
• Working knowledge of statistical methods as well as statistical application software.
  
• Good communication skills (verbal, written, and presentation)
• Ability to effectively manage time
• Ability to handle multiple task assignments.