Quality Assurance Engineer

Duties

• Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
• Aid in Coordinating a production and Engineering Team in a variety of manufacturing processes.
• Develop and implement new processes including DOE, IQ, OQ, PQ.
• Able to implement TAQ time analysis, life flow studies, and improvement plans in an ISO 13485 environment.
• Perform root cause analysis and help develop corrective actions.
• Develop and assist in the process and product monitoring, including the creation and documentation of validation protocols that comply with FDA regulations.
• Provide troubleshooting focus and direction for the team with details of root cause analysis.
• Utilizes DRM/COS/Lean principles to develop creative, thorough and practical technical solutions.

Qualifications

• Bachelor's degree is required in an Engineering - mechanical, polymer or material science discipline.
• Plastic products understanding & Injection Molding Experience
• Strongly preferred. Minitab and PFEMA Experience, defab.
• 8-15 years of experience in diverse technical, materials, manufacturing and process design.
• Experience in statistical analysis and statistical process control.
• Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment.