Quality Systems Engineer Galway Medical Devices

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Role: Quality Systems Engineer

Location: Galway

Industry: Medical DevicesYour role:

The Quality Systems Engineer will manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485:2016, MDSAP and FDA requirements. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.Duties/Responsibilities:

*Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.

*Lead preparation and coordination activities for external audits and liaise as required with SME's to ensure audits are conducted in an efficient manner.

*Co-ordinate the Document Control Function in conjunction with the appropriate resources.

*Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.

*Coordinate the complaints system to ensure that all complaints are completed in a thorough and timely manner.

*Co-ordinate quality system review activities and reporting.

*Promotes the awareness of regulatory and customer requirements throughout the organization.

*Supports Quality training on site.

*Methodical review approach and be capable of initiating and leading change and continuous improvement.

*Manage the Environmental Monitoring process and system for the manufacturing area etc.

Education/Experience:

A degree in Engineering, Technology, or Science

*At least 3-5 years' experience working in a regulated medical device or pharmaceutical company.

*Excellent planning and coordination skills.

*Excellent verbal and written communication skills.

*Excellent attention to detail skills. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales