Description
Quality Engineer - Validation - Limerick, Ireland
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 J&J policies and procedures.
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 introductions
- Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
Education and Experience
- 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
- Proven ability to review and critique Quality Critical technical documents.
- A good understanding and working knowledge of FDA and ISO regulations.
- Knowledge of lean manufacturing
- Experience as Quality Engineer working in a cGMP environment preferably in medical device.
- Positive attitude
Continuous Improvement orientation
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
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.