Cache of job #13790850

Job Title

Senior Global Quality Systems Engineer

Employer

Careerwise Recruitment

Location

Galway

Description

A Senior Global Quality Systems Engineer is required by CareerWise Recruitment for our Galway based Medical Devices client. The Snr. Global Quality Systems Engineer is a member of the Global Quality Systems department with primary responsibility for support of the QMS. THE ROLE: * Enhancement of the Quality Systems across sites, in support of global quality system activities. Working to develop and manage quality system requirements while coordinating the implementation of these requirements across multiple sites. The individual shall possess skills in FDA (QSR) and ISO 13485 quality systems in a medical device manufacturing environment. * The Senior Global Quality Systems Engineer may also from time to time assume other Snr Quality Engineering or Quality Management responsibilities relating to areas such as product disposition, Complaints, training - as deemed appropriate and based on experience and training. * Develop and implement world-class Quality System processes in support of the business requirements, working closely with site Quality leaders. * As a site matures (such as moving from component manufacturing to Finished Device manufacturing) lead the development of the site quality system to meet the additional requirements. * Ensure all aspects of the sites QMS (Management Reviews, Internal Audits, and Supplier Management etc.) are in compliance with the global quality procedures. * Represent Quality in customer meetings; represent the Global Quality organization and be able to outline the Corporate Quality system and principals as part of business proposals, QBRs etc. * Responsible for scheduling, planning, conducting, communicating and reporting on global internal audit results. * Liaise closely with the Project Management Office to be aware of NPI/transfers into the sites that could impact the QMS, and plan for such changes. REQUIREMENTS: * Degree in Engineering or Science. * Post graduate qualification in Quality or at least 5 years experience in a Quality Systems Engineering role. * Strong compliance, process and audit experience. Proficient problem solving and investigation skills. * Manage multiple tasks and accomplish them in a timely manner. * Ability to work on own initiative with remote management. * Trained lead auditor with experience in performing quality system audits. * Strong knowledge of ISO and FDA quality requirements. * Excellent attention to detail and report writing skills. ******Full and comprehensive Spec available on request****** Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

Date Added

2417 days ago

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