Quality Assurance Engineer

Quality Assurance Engineer

Nanobiosym is an innovative, high-tech company that is developing novel technologies at the nexus of physics, nanotechnology, and biomedicine. Founded by MIT/Harvard alum and located in Cambridge, Massachusetts, Nanobiosym was awarded the first X-Prize to be given for healthcare.

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.
• This is a hands-on leadership position in a growing organization and an opportunity which will grow rapidly.

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.

PERSONAL QUALITIES

• You have leadership skills to enhance team dynamics.
• You are passionate about new product development, healthcare, and mobile technology.
• You are methodical, detail oriented, well organized and effective at time management.
• You are a self-starter.
• You have good interpersonal, verbal communication, and documentation skills.
• You can function well in a challenging and fast-paced environment.
• You are enthusiastic and positive, with strong skills in the areas of dependability, flexibility, and maturity.