We are currently recruiting for a Document Control Specialist with one of our long-established clients based in Limerick City. Position will be offered on permanent contract basis with an attractive employment package and excellent working conditions.
Person will be responsible for multiple administrative duties within the Quality System of a Medical Device company including document control, records management, and serve as the Training Coordinator for Documents. Additional duties include maintaining compliant supplier records, archive and store quality records, and conduct internal audits. This position is responsible for ensuring that all records created and maintained by the company are in compliance with FDA, ISO, QSR, quality, safety and environmental regulations.
MAJOR DUTIES AND RESPONSIBILITIES:
-Lead and manage the document control function ensuring documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner.
-Serve as the company Training Coordinator to initiate, monitor and record training assignments and completions for all personnel. Maintain metrics and routinely report training status to executive management.
-Oversee and lead the Quality System metrics program to create timely status reports for executive management and ensure key Quality Sub-Systems are being properly maintained.
-Manage the External Standards program to ensure the latest standards are obtained, used, and referenced in reports and protocols.
-Manage the Quality System records storage and archival processes, assist in the record keeping development and tracking of critical quality processes such as CAPA, Complaints, Internal/External audit findings, and Non-Conforming Reports.
-Perform other Quality System duties in support of the Quality Assurance function as needed.
EXPERIENCE REQUIREMENTS:
-Required: Have 2 years of recent quality systems management experience working directly in a regulated environment.
-Strong administrative/computer skills.
-Preferred: Prior experience as a document control specialist in a medical device company.
eFlexes is an equal opportunities employer
