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.
Responsibilities:
- 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
Requirements:
- 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