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Senior Quality Systems Engineer

Real Staffing Group

Posted on Dec 27, 2020 by Real Staffing Group

Galway, Ireland
IT
Immediate Start
Annual Salary
Full-Time


Permanent position with a growing Medical Device company for a Quality Systems Engineer in Galway Business Park.


Job Summary:


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


Benefits:


Career progression, excellent salary, pension, healthcare and yearly bonus.


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.


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.


Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales




Reference: 1045235605

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