Risk Management - Essex, United Kingdom - Olympus KeyMed Group Companies

Tom O´Connor

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Tom O´Connor

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Description

Responsibilities:


In this position, you will be responsible for managing product risk management and DFMEA activities to ensure and support compliant, efficient and harmonized technology and product development as well as life cycle management.


  • Manage riskbased activities during product development to ensure the inherent safety of Olympus medical devices in use
  • Develop indepth understanding of the use environment, clinical users, and procedures to guide project teams in the deployment of risk management and DFMEA processes
  • Support post market surveillance activities to maintain market safety and regulatory compliance
  • Review legacy product risk management files to ensure compliance to current risk management regulations/standards
  • Manage all applicable risk management & DFMEA documentation in compliance with external standards and internal processes during product development as well as product life cycle management
  • Contribute to the implementation of global risk management strategy and the supporting key initiatives
Your qualification

  • Degree in Engineering or equivalent skill and knowledge gained through significant practical experience
  • Experience in a regulated and highly industrial or scientific engineering design environment
  • Experience and understanding of intellectual property
  • Experience in medical device development is preferred
  • Understanding of current medical device Risk Management standards (i.e. ISO 14971, IEC 60812)
Your competencies

  • Integrity
  • Empathy
  • Longterm View
  • Agility
  • Unity
Your benefits

  • In addition to a competitive salary, Olympus contributes greatly to employee pensions
  • You will be eligible for private medical cover
  • A generous annual leave entitlement that increases over your length of service
  • We support work/life balance with hybrid working and flexible hours
  • At our Essex HQ, we have a subsidised staff restaurant and free parking
  • Other benefits include discounted gym membership, a free annual health check and so much more

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