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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Quality Engineer


Reference:QE - Galway Location: Galway
Galway City
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

Role: Quality Engineer

Location: Parkmore, Galway

Benefits: Competitive salary, yearly bonus

Company:
Exciting Medical Device early stage company with sites in Ireland developing an innovative medical device technology to treat Benign Prostatic Hyperplasia.



Role:
My client are a Medical Device start up based in Dublin who are opening a new Manufacturing site in Parkmore, Galway for their product. Currently using contract manufacturers they are looking for a Quality Engineer to come on board and help develop their own manufacturing line and Development of quality plans, programs and procedures, through all aspects of the product development process.


You will be working on maintaining the Quality Management System as well as work with R&D, clinical, manufacturing, and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements.


Responsibilities:

  • Development of quality plans, programs and procedures, through all aspects of the product development process.
  • Assist in development of quality plans, procedures, work instructions, inspections for manufacturing process
  • Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
  • Ensure that performance and product quality conforms to company, customer and regulatory requirements.
  • Review, analysis and reporting on quality discrepancies related to product design and manufacture.
  • Assists in supporting external audits.


Skills/Experience:
  • Bachelor’s degree in a relevant Engineering or Science field
  • 1-3 years’ experience in the medical device industry or other regulated industry
  • Strong verbal, written, organizational, time management and interpersonal skills
  • Strong computer skills, including working knowledge of MS Office and e-mail
  • Knowledge of medical device quality systems and medical device directives (ISO13485 and FDA CFR 820)



Would you like to develop your career in an exciting start up in Galway? If this sounds like you and you would like to know more apply today or contact me at [email protected] or forward your CV to the link provided.