Description
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
Key cGMP Responsibilities :
- Follow Standard Operating Procedures at all times.
- Follow required applicable Regulatory standards as required
- Ensure compliance to the QMS.
- Follow Personal Hygiene Rules as defined in the GMP Training Programme and notify area supervision of any health conditions which may affect the quality of product.
- Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner.
Qualifications and Experience 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.
If you are interested in this opportunity or know anyone who might be, please contact Sarah Irvine on or respond to this advert. We also offer £200 vouchers for any successful referrals.