Description
Quality Engineer - Validation/Limerick/12 Months Contract/25 to 34 EUR (Per Hour)
Quality Engineer - Validation
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 policies and procedures.
Responsibilities:
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
Education and Experience Required for Role
Essential:
- Bachelor's degree from accredited college -plus experience 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
- Project Management 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.
Experience and Education
- Significant experience in a regulated environment.
- SIX SIGMA - Certification
- Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
- Experience of the design and qualification documentation standards to current FDA expectations
- Knowledge of statistical packages and Microsoft Office systems required.
- Proven ability to review and critique Quality Critical technical documents.
- A good understanding and working knowledge of FDA and ISO regulations. Desirable
- Knowledge of lean manufacturing
- Experience in performing Design of Experiments (DOE) and leading
- Experience as Quality Engineer working in a cGMP environment preferably in medical device.
- Continuous Improvement orientation.
Must have good written and presentation skills and be able to communicate effectively throughout organization. Demonstrated Experience working with data base applications desired Experience in performing Design of Experiments (DOE) and leading
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.