Senior Quality Systems Engineer

Cork, Tipperary, Waterford, Ireland
May 18, 2018
May 21, 2018
Contract Type
Full Time
Job Type
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for multiple contact lens sites is in compliance with current Medical Device Directives, ISO 13485 and applicable global regulations & standards for all identified products This position will also perform activities required to maintain an agile, efficient quality system including developing & reporting relevant metrics to the global business unit leader for all applicable sites under the Legal manufacturer's responsibility as well as the generation and maintenance of relevant Quality Performance Metrics Principal Responsibilities: Setup, maintenance and continuous improvement of Quality Management System for contact lens legal manufacturer Creating quality agreements for outsourced processes Set up and manage documentation control and repository for QMS documentation 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 Participate in the preparation and execution of inspections with relevant authorities & internal compliance group Project support as determined by Snr Quality Director for Contact Lens Requirements: Bachelor's Degree in a quality, scientific or engineering discipline Previous experience  managing a  quality management system for a medical device or pharma site. Previous experience writing quality agreements Previous experience preparing for and executing regulatory inspection Previous experience of implementing changes Cross functional team experience Working Knowledge of MS office Working knowledge of QMS systems e.g. change management, CAPA, Nonconformance etc Good communication skills ( verbal & written ) Decisive, self-motivated/capable of working on own initiative, and able to prioritise and a proactive approach High attention to detail Medical Device experience CGMP