Your new company :
Here in Hays Recruitment our Medical Device client in Limerick is hiring for a Quality Engineer. They should have a keen aptitude for implementing and maintaining standards and driving efficiency within the business.

Your new role:
In your new role you will be Reporting to the Business Unit Quality Manager/Staff Validation Engineer, this role is responsible for establishing and ensuring adherence to standardised validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.

Responsibilities:

• Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.
• Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.
• Runs /Manages complaint investigation and resolution of same
• Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements.
• Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation.

What you'll need to succeed :
Education and Experience:

• A bachelor’s degree from accredited college
• 2/3 years in a Quality function within the Medical Device/ Pharmaceutical industry.
• Experience in non-conformances / change control / validation
  Desirable:
• Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.
• Have good knowledge of statistical techniques in the use of problem-solving/ data analysis.
• Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management.
• Ability to demonstrate standards of leadership – Managing Complexity/Values/ Innovations/Customer focus.

What you'll get in return :
The opportunity to develop and grow your career in a Multinational organisation.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

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