Senior Quality Engineer Post Market Surveillance

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Industry: Medical Devices

Contract: 24month FTC

Division of Role: Post Market Surveillance

Location: GalwayDue to ongoing expansion, a highly reputable client of ours in the medical devices space have an opening for a Senior quality professional to join their team in Galway.The successful candidate will work within the Divisional Post Market Surveillance team which supports and guides the Business Units in discharging their regulatory obligations to conduct Complaint Handling, Vigilance reporting and Post Market Surveillance activities. Responsibilities:

-Contributes as part of a geographically dispersed team of quality and data analysis professionals that constitute the Divisional Post Market Surveillance team.

-Possesses and applies comprehensive knowledge of Quality, and its application to the field of Complaint Handling, Vigilance Reporting and Post Market Surveillance.

-Support Global Business Units in executing on Complaint Handling, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines

-Obtain a thorough knowledge of global operations and structures in order to enable informed decisions and to provide direction to BU Quality and Regulatory teams and other functional areas.

- Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.

-Drives compliance cross functionally in alignment with the divisional for collaboration and multi-site adherence to relevant regulatory requirements.

-Drives business improvements through continuous improvement initiatives.

-Responsibility for delivery of projects on behalf of the Division and with the support of the Business Units

-Escalation point for quality related non-conformances and CAPAs.

Qualifications (essential):

-3rd Level Qualification in related field (Science, engineering or nursing preferable)

-Min 8 years of experience in medical device industry with minimum 3 years experience in post market surveillance and working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)

-Experience working in electronic complaint management systems

-Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.

-Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.

-Excellent computer skills including all MS Office applicationsDesirable:

-Experience supporting in-vitro diagnostics products

-Experience managing customer complaints for medical device or in-vitro diagnostics

-Broad knowledge of engineering and technical applications applied in development of medical devices usefulIf this role if of interest and you would like to be considered apply today with n up-to-date CV. Feel free to pass onto anyone in your network who also might be interested. 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