Our Client, A leading Medical Device company based in Clare, are seeking a Quality Specialist to join their team. The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System. The QMS includes medical device design and Development Manufacture and secondary packaging and distribution of medical devices. The ideal candidate will have experience working in a fast-paced, dynamic environment.Responsibilities include but are not limited to:Following, fostering and implementing a quality culture and other company manufacturing standards, policies and proceduresEnsure the effective implementation and maintenance of the Quality Management System.Support the operation of QMS functions, such as: Change Controls, CAPAs and Non-Conformance documentation, documentation control, employee training, design & development controls.Investigating and troubleshooting problems, determine solutions or recommendations for changes and/or improvements, utilize tools such as root cause analysis.Drive continuous improvement initiatives based on quality objectives.Perform QA Verification of activities performed in production.Review and update Quality System documentation (procedures, reports) as required.Participate in preparation for and execution of internal & external audits from customers, Notified Bodies, Competent Authorities.Generate reports as required and assist in any other data compilation as required.Leading qualification & validation activities, such as equipment, processes, test methods, software.Review & approval of Batch Records/ Device History Records.Third level qualification in natural sciences (Certificate, Diploma, Degree level)Previous experience in a highly regulated environment (pharma, food, med devices)Good planning and organizational skills.Good communication skills (oral and written).Hardworking and highly motivating individual, with good attention to detail.Proficient in use of Microsoft Office.Ability to work both independently and as part of a team.Ability to work in a dynamic environment, with changing priorities.Advantageous:Previous experience working with NPI’sExperience in Startups and SMEsNote: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce