Collins McNicholas

Role Responsibilities:

  • Responsible for maintaining the design control activities associated with the Medical Device portfolio.
  • Ensure Design History Files are in compliance to the latest Quality and Regulatory requirements.
  • Assess change controls for impact to Product Design History Files & Design Verification.
  • Support sustaining commercial projects from a Design Assurance perspective.
  • Be involved in making sure products are maintained through the full product lifecycle and that these products comply with global standards.
  • Support the introduction/implementation of product/process/materials changes to the manufacturing operation.
  • Assess the risk appropriately for these design changes.
  • Provide QA technical direction/input to qualification and validation activities in conjunction with Mfg. Engineering.
  • Responsible for generation and completion of Design Verification protocols & design verification reports.

Role Requirements:

  • University degree in a Science or Engineering related discipline
  • 3-5+ years of experience in design assurance, new product development or related medical device experience
  • Self-starter and independent critical thinker, with the aptitude to work autonomously and within a team 
  • Strong interpersonal, organizational, and project management skills
  • Demonstrated use of Quality tools/methodologies.

 

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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