Quality Systems Engineer

 

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.

Organization Collins McNicholas
Industry Engineering
Occupational Category Quality Systems Engineer
Job Location Galway,Ireland
Shift Type Morning
Job Type Permanent
Gender No Preference
Career Level Intermediate
Experience 2 Years
Posted at 2023-04-12 10:10 am
Expires on 2024-12-05