Quality Engineer

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

• Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
• Ensure documentation and procedures are followed 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.
• BS or BA in related field required with up to 2 years of experience, or MS with no experience required.
• Typical degree in Mechanical or Electrical or Industrial or Biomedical 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).
• 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.
• Utilizing TRACKWISE software is an advantage.
• 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.