Quality Systems Engineer
Reporting to the Quality Manager, the Quality System Engineer is a team member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System onsite.
Working in the QA Dept, this person will have day to day responsibility for the running of QA based systems; document control, monitoring and development of all Quality System components running of NCR and CAPA systems, oversight of Labelling control system.
The successful candidate will liaise and collaborate with various departments including engineering, operations etc. to ensure the quality system is in compliance. This role includes people management and the successful individual may have up to a team of2 reporting directly to them.
Major Roles & Responsibilities:
This role will involve reasonability for the following;
• Identify and implement effective process control systems to support the continuous improvement of the quality systems as a whole.
• Oversee and be actively involved in all QA office systems and functions.
• Direct involvement in routine Document Control, NCR and TA activities.
• Develop and implement quality metrics and reporting systems.
• Support and deliver continuous improvements and to employ problem solving tools including root cause analysis and CAPA identification.
• Preparation of Quality reports for Quality meetings and management reviews.
• Oversee all in house label control systems.
• Acts as an effective team member in supporting quality disciplines, decisions and practices.
• Facilitate the New Product Introduction processes along with other Engineering functions to ensure NPI procedures are efficient and effective in satisfying the QMS/ Customer requirement.
• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.
• Ensure regulatory compliance to GMP for all medical device regulatory agencies.
• Participates in new product/technology development and supports the QA activities as part of an overall project team.
• Perform an active role in continual improvement of the Quality System.
• Conduct internal quality audits to ISO13485 and GMP requirements.
• Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.
• Undertake special projects as required.
• Contribute to continuous improvement activities.
• Take part in third part audits as required.
Knowledge and Skills Required:
• Demonstrable Knowledge of medical device quality systems and ISO13485.
• Excellent Computer Skills (word, excel, PowerPoint and Access).
• Excellent communication (both verbal and written) & interpersonal skills.
• An analytical approach to problem solving.
• A self-starter that applies their own initiative in most situations.
• A team player, who works well in a smart team environment, must be able to work effectively with peers in other departments.
• A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
• CAPA, Auditing and Risk Management experience.
• Good organisational skills and ability to track and drive activities to closure.
Qualification and Education requirements:
• Requires a Level 8 or higher degree in an engineering or science discipline.
• Previous experience within the medical device industry in a Quality Systems Engineer role is essential.
• Minimum of 4 years of quality experience in a quality function with proven quality assurance experience within Medical Devices.
• Recent experience with FDA/NDSAP GMP requirements is highly desirable.