Senior Quality Engineer
Our client, a medical device company in Limerick are currently looking to recruit a Senior Quality Engineer for their site.
- Short statement stating exact purpose of the role:
- Support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations
- Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions.
- Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
- Implement company policies and procedures.
Main areas of responsibility:
- 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 introductions
- Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
- All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Education and Experience Required for Role
- Bachelor’s degree from accredited college
- 3/5 yrs. in a Quality function within the Medical Device/ Pharmaceutical industry.
- 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/Credo Values/Innovations/Customer focus.
- Team Player
- Good Influencing Skills
- Project Management Skills
- Good generalist
- Good communication skills
- Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.
For further information on this Senior Quality Engineer role in Limerick please contact Caroline Kingston on 0868395531 / firstname.lastname@example.org
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