Description:
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.
Responsibilities:
- 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 the 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 the 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.
Requirements:
- 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 organization.
- CAPA, Auditing, and Risk Management experience.
- Good organizational skills and ability to track and drive activities to closure.