Quality Systems Engineer Ii

Sigmar Recruitment

Galway

Quality Systems Engineer II. This is a very exciting time to join a growing and evolving Internal Audit team with a large scope to reshape the team and how they operate in a changing environment.  The role is diverse with a hands-on element of conducting audits along with a strategic role of shaping the function and partnering with the business. What you will do: Demonstrate a primary commitment to patient safety and product quality. Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Drives changes in procedures and standards to facilitate work efficiency and to maintain quality. Familiar with the internal auditing system. Acts as a leader of quality, QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.   What you will have: NFQ level 8 (240 credits) in Science, Quality or any other STEM discipline. Minimum requirement 3-5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS. Strong understanding and experience in the implementation of ISO 13485, ISO 14971, MDR. Dynamic team player who will lead intra/inter-departmental teams and/or projects that support continuous improvement of the Quality Management System. Builds positive support and acts as role model for change. May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management. Leads intra or interdepartmental teams of an operational nature such as preparing the company for minor changes in regulations, continuous improvement initiatives. Accredited lead auditor against recognised quality standards in support of internal audits. Must be able to organise and prioritise tasks, must be detail orientated and self-motivated. Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals along with coach / mentor the organisation audit function. Effective compliance reporting to senior management and relevant quality governance forums. Must have excellent written and verbal communication skills. What you will receive: Competitive salary & benefits package, career advancement & development opportunities. To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie   All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.  .

1249 days ago