Quality, Validation, Medical Device, Regulations
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.
- 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
- 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.