Document Control Administrator - Galway, Co. Galway Company Information: Our client is a leading provider of medical device design and manufacturing.The company is committed to delivering innovative and quality solutions that save and improve lives around the world.
Known for its industry-leading standards and focus on innovation,offeringa dynamic environment for professional growth and development.
Role Profile: As a Document Control Administratoryou will be responsible for supporting the administration and maintenance of the Electronic Quality Management System (eQMS) and SAP System within the organization.
Key responsibilities will include (but aren't limited) to the following; Support the administration and maintenance of the eQMS.
Act as the Quality Subject Matter Expert (SME) for eQMS within the organisation.
Own and manage the various components of the current operational Quality Management System.
Support quality system compliance activities and follow up to ensure satisfactory closure of identified gaps.
Complete internal audits and assist in preparation for external, supplier, and regulatory audits and audit follow up activities.
Qualifications / Professional Skills / Knowledge Diploma qualification in Quality or a related discipline or significant relevant experience in a quality systems role within the Medical Device Industry.
Thorough knowledge of medical devices quality systems and associated regulatory requirements (ISO 13485, FDA etc.)
A minimum of 3 years experience in a similar Quality related role in the Medical Device industry.
Experience working with eQMS, SAP and Assent systems a distinct advantage.
Excellent attention to detail.
Good communication skills both verbal and written.
Fluent English skills required.
Benefits: Competitive Salary Health Insurance Paid Holidays.
Company Pension Education Reimbursement If youre interested in this opportunity, please contact Brendan ator call Skills: SAP eQMS ISO13485 Benefits: Pension Life Assurance Permanent Health Insurance