Risk Management Quality Engineer

Designation: Engineer

Location: USA

Qualification: Bachelor’s Degree


Risk Management Quality Engineer needed to perform the following Job duties : 

  • Execute and support on-time completion of Risk Management Deliverables
  • Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
  • Support Risk Management / Cybersecurity activities from product Concept through product obsolescence.
  • Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Bachelor’s Degree Required in   Mechanical Engineering or Industrial Engineering or Industrial Management.  

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