Description
Senior Quality Manufacturing Engineer
Detailed Description
- Preventing the release to stock of product not meeting all specifications.
- Where appropriate, to refer dispositioning of non-conforming materials to Quality Director and/or Regulatory Affairs/Global Quality.
Principle Job Responsibilities/Outputs:
- To oversee Product Quality that meets Customer requirements.
- To Manage Non conforming product and ensure effective resolution of Quality problems
To assess & challenge established Quality Systems and Quality methods with an objective to improve overall system effectiveness, and to reduce product and process risk. - To apply both a Lean and Six Sigma approach for improvements to the Manufacturing Quality Systems.
- Drive quality improvement initiatives in combination with Process Engineering and Operations
Conduct/assist with problem solving investigation, root cause and risk reduction analysis across processes. - Development of efficient and compliant systems that meets both business needs, regulatory requirements and global specifications.
- Support and risk manage process change initiatives to ensure appropriate level of validation and verification.
- Work in partnership with operations and process engineering to drive quality and cost improvement initiatives.
Educational Details Required
- Third level qualification, ideally in Engineering or Science.
- 5 years experience in Healthcare or Electronics industry.
- Strong analytical skills with good knowledge of applied statistics and process control systems.
- Knowledge of Six Sigma and Lean tools
- Self motivated with ability to lead a core team to meet the above objective.
- Must be familiar with the regulatory requirements of the FDA and/or ISO.
- Decisive, good communicator, self-motivated, have record of achievement and be a good team member.