Quality System Manager

Brightwater

Waterford

A key client in Waterford has just created a new position in their Quality structure to manage the roll out of the changes required by the new Medical Device regulations. You`ll be a major figure in the examination, realignment and management of their quality system and documents at their global manufacturing facilities. The role is fully based in Waterford and has an exceptional salary and benefits package. You will also perform gap assessment for MDD, ISO and MDR identifying and remediating gaps in the QMS and change management activities for the implementation of MDR QMS requirements. Principal Responsibilities: Setup, maintenance and continuous improvement of Quality Management System. Responsible for updating the QMS for the legal manufacturer & business unit QMS to comply with existing & emerging quality regulations & standards. Responsible for working with functions , outsourced processes & manufacturing to determine the legal manufacturer architecture , associated documentation and associated governance. Lead the legal manufacturer audits with relevant authorities & internal compliance group. Requirements: Have 5 years+ experience as a senior QSM in the medical device industry. Previous experience working with virtual teams. Strong written and verbal communication. Strong influencing ability. For more on this exciting role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2164 days ago