Our client, a medical device engineering company in Sligo, is offering a range of development and manufacturing services from initial design assessment to the provision of sterile finished products for the European and US medical device market.
They are seeking a Quality Assurance Engineer to join their team.
Responsibilities include but are not limited to: Provide technical quality support to Project Manager, Design Engineers, Production Manager, and clients.Work closely with the Engineering team and the client to establish and maintain compliant product specifications.Quality review of process validation plans, protocols, and reports.Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.Issue, review, and release lot records to manufacturing.Co-ordinate and review testing and release of sterilized products.Quality review of SOPs, Work Instructions, Templates, Material Specifications, etc., to ensure compliance with applicable regulatory standards and cGMP procedures.Review and approve product change controls.Liaise with suppliers and clients on quality-related issues.Perform an active role in further development and continuous improvement of the QMS.Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints.Perform CAPA reports.Support clients in product submission to applicable regulatory authorities.Support the Quality Department in implementing and maintaining QMS.Conduct internal audits and compile associated documentation.Support and assist in the preparation for customer and surveillance audits.Update job knowledge by participating in educational opportunities.Other duties as assigned by the manager.Job RequirementsMinimum Degree in a Science or Engineering discipline.3-5 years' experience working in a medical device environment.Strong knowledge of ISO 13485, FDA regulations 21CFR 820.Strong knowledge of MDR & FDA product submission requirements.Internal/external auditing experience would be an advantage.Validation experience, including Sterilization, process, and packaging validations would be beneficial.Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.Strong understanding of the general principles of ISO 14971.Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritize.Demonstrate detailed working knowledge of the medical device industry.Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers, and customers.Self-motivated, flexible with a desire to learn new tasks.Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives.Capacity to maintain the highest level of confidentiality internally and externally.High level of teamwork and engagement.
#J-18808-Ljbffr