Collins McNicholas

Excellent opportunity for an experienced Biocompatability Specialist to join my client’s team in Galway.

Role Purpose: Ensures that biocompatibility validations are conducted in line with all quality system and regulatory requirements. 

Responsibilities:

  • Demonstrate a primary commitment to patient safety and product quality.  
  • Understands and complies with all the regulations governing the quality systems. 
  • Performs or coordinates a wide variety of biological or chemical tests which are performed in accordance with approved protocols and summarizes the results in a final report or qualification.
  • Validates new and existing products to ensure compliance with current biocompatibility regulatory standards.
  • Supporting and providing technical guidance in the development of product design, specifications and associated test methods.
  • Participates in product development teams to ensure validation of products to agreed timelines. Assists in documentation of validations for regulatory submissions.
  • Other duties as assigned, such as: approval of test reports.
  • Decision-making ability coupled with the ability to work on one’s own initiative, and with the minimum of supervision is required. Good interpersonal and communication (written and verbal) skills are required.
  • Good administrative/organisational ability is required.
  • To build quality into all aspects of work by maintaining compliance to all quality requirements.
  • HETAC Level 8 in a relevant field with a minimum of 2-3 years’ experience in a role.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well as part of a team & on own with minimum supervision

 

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For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email edyta.fleming@collinsmcnicholas.ie.

 

 

 

 

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