Quality Engineer / Validation
Reporting to the Business Unit Quality Manager/Staff Validation Engineer, this role is responsible for establishing and ensuring adherence to standardized validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.
- 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
- 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
- A Bachelor’s degree
- 3-5 years 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