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Quality Assurance Engineer

Nanobiosym

Cambridge, MA

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JOB DETAILS
SKILLS
Biomedicine, Code of Federal Regulations, Communication Skills, Corrective Action, Detail Oriented, Digital Rights Management (DRM), Documentation, FDA (Food and Drug Administration), FDA Requirements, Healthcare, High Tech Industry, ISO (International Organization for Standardization), Identify Issues, Injection Molding, Interpersonal Skills, Leadership, Life Time Analysis, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Material Science, Mechanical Engineering, Minitab, Mobile Technology, Nanotechnology, Organizational Skills, Physics, Polymers, Presentation/Verbal Skills, Process Management, Process Validation, Product Development, Quality Assurance, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Statistical Process Control, Statistics, Time Management, United States Department of Energy (DOE), Validation Documentation, Validation Plan
LOCATION
Cambridge, MA
POSTED
22 days ago
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.
The Compliance Engineer is responsible for the organization and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for compliance

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.


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Nanobiosym

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