Currently looking for a dynamic individual to work as a Quality Assurance Coordinator for a medical device multinational located in Dublin North. The Quality Assurance Coordinator will plan, coordinate, and direct the quality system to ensure documentation and standards of quality management system meet ISO 9001 and ISO 13485 standards. The coordinator will ensure that processes needed for quality management are established, implemented and maintained through internal and external audits.
· Responsible for supporting the Quality Management System.
· Develop and maintain quality assurance objectives in support of company policies and goals.
· Responsible for ensuring that the SOPs, forms, and quality documents are maintained and updated at the revision levels and distributed in quality systems.
· Train teams to reduce quality problems and increase understanding of quality goals.
· Analyse data, create reports and communicate feedback.
· Responsible for internal quality audit program and ensuring audits are completed according to schedule and corrective actions are tracked and completed.
· Communicate internally and with customers on complaints and investigations; assist in the preparation of reports on customer complaints, investigations, quality trends, and other quality Key Performance Indicators (KPIs).
· Audit and track supplier quality performance; coordinate Non-Conforming Process for suppliers and internal issues.
· Assist in performing the training of employees with respect to Quality System, Root Cause Analysis (RCA), and various QA standards.
· Document current state, risks, and process improvement goals
· Bachelor’s Degree preferred but not essential in lieu of experience.
· Minimum 3 years of experience in manufacturing within the Quality Control/Quality Assurance environment, preferable in the medical device sector
· Quality Control exposure, ISO 9001, ISO13485 desired
· Ability to learn new techniques, perform multiple tasks simultaneously and keep accurate records.
· Detail oriented with a strong sense of safety awareness.
· Excellent oral and written communication skills and is able to communicate effectively