Quality Engineer

Roles & 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.

Experience

• Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
• 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. Working knowledge of statistical methods as well as statistical application software.
• Effective verbal and written communication skills. The ability to work in teams and independently with minimal supervision to obtain results as required.
• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).

Education

• BS or BA in related field required with 2 years of experience, or MS with no 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.