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QUALITY ASSURANCE OFFICER - 6 MONTH CON

 

Company:

COLLINS MCNICHOLAS RECRUITMENT
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Job Reference Number

13467783

Client ID:

RI/SJ03947Y
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Posted On:

Jun 14 2009

Location:

SLIGO
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Job Type:

Contract

Salary:

NEGOTIABLE
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Our client based in Sligo requires a Quality Assurance Officer for a 6 month fixed term role. Reporting to the Quality Assurance Manager, the responsibilities of the successful candidate will include:

CMDCAS Quality systems - Canadian certification:

  • Update Quality manual and related SOPS, forms and lists to incorporate the Canadian requirements.
FDA Quality systems:

  • Assist in the development of a Global Quality manual. The Global Quality manual will need to incorporate the FDA medical device QSR requirements which will dictate the requirements of all the Quality systems impacting on the medical device.
  • Update the Quality manual and all related SOPS, forms and lists, to reflect the requirements of the Global Quality manual.
    The manual and related procedures will require ongoing maintenance.
  • Liaise with the contract manufacturer with regard to maintaining compliance and implementation of any future requirements. Ensure systems are set up with the manufacturer where all relevant information feeds into the Quality systems. These systems will require ongoing maintenance.
  • Manage all changes relating to the product at the manufacturer. This will require on going support.
  • Interfacing with the manufacturer / Global R&D / Supply chain and market surveillance. Liaise with project team to help perform project related activities in an efficient and effective manner and in tandem with other related Global project related activities.
  • Monitor and approve raw material suppliers for the manufacturer.
  • Compilation of the Bi-Annual Quality review.
  • Maintain up to date knowledge of all standards relating to the medical devices for all markets. (ISO standards, Med dev, CMDCAS and 21CFR 820)
  • Management of technical file ensuring changes and/or required additions are in compliance and file is kept up to date.
  • Maintain current and future quality system compliance relating to medical devices. This includes meeting the regulatory requirements of the European, Canadian and US markets.

The successful candidate will:

  • Have a third level qualification in a relevant scientific discipline (essential).
  • Have a thorough understanding of laboratory procedures and laboratory skills, the practices, principles, and theory of specific disciplines.
  • Have previous project management experience (desirable).


The successful candidate must have a proven record to show:

  • Ability to apply scientific principles and techniques.
  • Ability to work effectively in a pressurised environment, exercising good judgment and making timely and well informed decisions
  • Excellent communication skills, both verbal and written, to individuals and groups
For further details, please contact Niall on 071 9142411 or email niall.murray@collinsmcnicholas.ie