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Senior Risk Consultant

1 month ago

Ohio City, Ohio, United States eTeam Full time
About the Job

We are seeking a highly skilled professional to join our eTeam as a Senior Risk Consultant. In this role, you will lead and coordinate process, practice, procedures, and technology adoption for the continuous improvement of risk management work product and deliverables for projects and programs.

About eTeam

eTeam is a company that specializes in providing innovative solutions for the medical device industry. We pride ourselves on being at the forefront of risk management and quality assurance.

Key Responsibilities

The successful candidate will be responsible for:

  • Providing risk management leadership, expertise, guidance, and supervision during all project phases from initiation through end of life.
  • Development of efficient and robust processes, procedures, practice, tools, and technology to support continuous improvement in risk management.
  • Leads development and implementation of key performance indicators (KPI's) and metrics for the risk management process and metrics.
  • Leads and conducts SWAT assessments in risk management to support continuous improvement across business processes.
Skill Requirements

To be successful in this role, you must have:

  • Bachelor's Degree in Engineering (Mechanical, Systems, Chemical or Electrical) or Science (Mathematic, Chemistry).
  • 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971) to Class II and Class III medical devices.
  • Expertise in the application of Statistical Techniques to support Design of Experiments, Design Verification, and Design Validation.
  • Expertise in DFSS techniques (Design Optimization and Characterization).
  • Expertise in industry best practices and advances in Risk Management practices, process, tools, and technology.