Risk Management Specialist

☞ Real Staffing

View: 107

Update day: 07-05-2024

Location: Runcorn North West

Category: Finance / Bank / Stock Sales

Industry: Research Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Our client is a fast growing medical device manufacturer developing diagnostic solutions for global customers. Fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Due to growth they are now looking for a Risk Management Specialist to join the fold.

Accountabilities
  • The Risk Management Specialist will own Global Product Risk Management process
  • Perform and supports Risk Analysis with accordance to the ISO14971
  • Conduct Hazard Analysis execution with Design Validation Specialists
  • DFMEA/FTA execution with R&D/EPD Engineers
  • Identify and manage Essential Design Outputs, CTQs and Product Critical Components
  • Assess risks within new designs proposals and influences developments
  • Assess the Design Changes Requests (DCRs) for risk management and execute risk strategies, as required
  • Ensure the implementation of risk control measures is effective and suitable for regulatory submissions
  • Perform Risk/Benefit analysis for existing and newly identified residual risks
  • The Risk Management Specialist will Conduct required RMF reviews and state of the art status for Post Market Surveillance activities
  • Work with Sourcing and Supplier Quality teams to ensure delivered product is compliant with the risk strategy
  • Participate in complaints reviews and root cause analyses (5Why, Ishikawa, A3, 8D) to determine appropriate risk evaluations and risk controls
  • Participate in product and related processes NCRs & CAPAs investigations
  • Continuously improves the process maintaining its effectiveness and compliance
  • Act as the SME for Risk Management during certification audits (ISO13485)


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To find out more about Real please visit www.realstaffing.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
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Deadline: 21-06-2024

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