Collins McNicholas

Role Purpose:

The primary function of the Senior Quality Systems Engineer is to provide support to the MDR team and ensure all required objectives associated with 2017/745 (MDR) are implemented in the lens manufacturing plant. This role will report to the Quality Systems Manager.

 

Role Responsibilities:

  • Assist with the execution of Medical Device Regulation in the manufacturing plant as identified by the MDR Project team
  • Implement any Plant Quality systems changes as identified by the MDR Project team
  • Implement plant Change management activities for the implementation of MDR QMS Requirements
  • Provide Supplier Quality support to any supplier changes / material changes that will occur due to MDR
  • Support new MDR Requirements around post market surveillance
  • Work closely with the plant ensuring clear communication of any new MDR requirements
  • Support risk management, risk analysis and health hazard analysis associated with post market information.
  • Additional requirements of the job will be specified by the Quality Systems Manager

 

Role Requirements:

  • Third level qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Systems Engineering role.
  • Experience working with an ISO13485:2016compliant quality system essential.
  • Operational Excellence Training advantageous
  • Self-directed and results driven team player.  Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
  • Strong problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
  • Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organization.
  • Excellent organisational skills, ability to take on and drive a project

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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