Quality Engineer 4

  • Location

    Newark, United States

  • Sector:

    Business Professional

  • Job type:


  • Contact:

    Sonu Chouhan

  • Job ref:


  • Published:

    over 1 year ago

  • Expiry date:


Risk Management Consultant

Principle Duties and Responsibilities:

This position supports the timely implementation of In Vitro Diagnostic Regulation (IVDR) risk documents. These documents need to be remediated, or created according to the program implementation schedule.

This individual will be responsible for gathering documentation related to our Risk Management Files, reviewing risk documents for compliance, and remediating/recreating risk documentation as necessary. The IVDR Risk Management Consultant will be responsible for updating and/or creating new dFMEAs and pFMEAs from scratch, writing Risk Plans, Risk Reports, Performance Evaluation Report Statements, and Post Market Surveillance Report Conclusion Statements.

The Risk Management Consultant will also work with R&D and Manufacturing groups on FMEA Remediation, as well as with Post Market Surveillance and Clinical Affairs groups to assess Overall Residual Risk and Risk-Benefit analysis as needed. There will likely be additional cross-functional support required in creating/optimizing Product Family Groups to encourage project efficiency. This individual will be responsible for executing risk documentation deliverables within an already created Risk Management Template.

This individual must be comfortable in a hands-on role, with strong experience in Risk Management (ISO 14971:2012), 21 CFR Part 820, Design Controls, Risk Controls, dFMEA & pFMEA review/remediation/creation, Risk Classifications, Post-Market Risk Management, Clinical Risk-Benefit Analysis, Root Cause Analysis, and Change Control/Design Changes. This IVDR Risk Management Consultant should also have experience using SAP to identify and manage the documentation.

EU IVDR or EU MDR project-experience would be a plus, and experience using Documentum would be a huge plus (experience with similar Electronic Document Management Systems will suffice). Required:

  • Bachelor of Science in Engineering, and at least 5 years experience in medical devices and / or diagnostics industry as a risk management professional
  • ISO 13485:2016
  • Risk Management (ISO 14971:2012)
  • dFMEA & pFMEA (Identify/Review/Remediate/Rewrite)
  • Design Changes & Design Changes (21 CFR Part 820)
  • Risk Classifications & Risk Controls
  • Post-Market Risk / Clinical Risk Benefit-Analysis
  • MS Excel
  • Experience using Electronic Document Management Systems

Preferred Experience:

  • IVD/Assay Product Experience
  • EU IVDR or EU MDR Project Experience
  • Familiarity with SAP, Team Center and Documentum

This is a one year contract with the possibility to extend.