Quality Engineer

• 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

• BS or BA in related field required with 2 years of experience, or MS with no experience required (project management experience preferred)
• 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
• 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

Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)