Description
Detailed List of Main Areas of Responsibility:Responsible for supporting the activities of Operations /Engineering /Information Management in building product Quality into 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 system upgrades.
To run/manage complaint investigation and resolution of same designs and develop validation documentation to support business continuity, new process introductions.
Essential:
Bachelors 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/Innovations/Customer Focus.
Team Player
Good Influencing Skills
Project Management Skills
Methodical
Desirable:
- 5 yrs 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.
- Knowledge of lean manufacturing
This is an urgent opportunity to join an exciting company with competitive rates. If you would like to apply for the position or know someone who would please contact Sarah Irvine on .