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Senior Quality Systems Engineer

Reference:JCAO3003
Location: Galway
Qualification:Degree
Experience:5-7 Years
Job Type:Temporary Contract
Salary:Not Disclosed
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May be suitable for: Senior Quality Engineer

Senior Quality Systems Engineer



Our client an indigenous Irish Medical Device company are currently seeking a Senior Quality Systems Engineer to join their team. Senior Quality Systems Engineer will lead key elements of the Quality System to ensure compliance to relevant standards for the business including EN IS013485:2016, FDA QSR and MDSAP. The role will take the lead in ensuring that areas of the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. Lead and direct the NC/CAPA and Document Control functions to ensure quality and regulatory compliance. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.

Roles and Responsibilities:
• Responsible for the document control function including co-ordination of DCR process and ongoing compliance, in conjunction with the appropriate resources.
• Assist the quality systems team with the implementation of a new QMS software-based solution.
• Responsible for the Q Pulse record management system (the computerized quality system tracking tool) and Quality records storage.
• Generation of reports for data trending and analysis of the quality system (as required).
• Responsible for all phases of the approval process for specific events and investigations.
• With the support of subject matter experts (SMEs), drive investigations, perform robust root cause analysis, develop and implement corrective actions, and establish effectiveness monitoring plans.
• Serve as a resource to investigations for conducting root cause analysis and developing and implementing corrective action plans.
• Maintain and manage positive working relationships and ensure appropriate representatives from affected departments are involved.
• Ensure that every activity performed in the QS process is accurately documented and that all timeframes for reporting or resolution are met.
• Complete internal audits and assist in preparation for external audits, as required.
• Aid in generation of management review metrics as required.
• Other tasks as assigned by the Quality Systems Manager.


Skills/Experience:

• Bachelor’s degree (Hons) in Engineering, Technology, or Science. (Level 8).
• At least 8 years’ experience working in a regulated environment.
• Previous people management experience.
• Excellent planning and coordination skills.
• Excellent verbal and written communication skills.
• Excellent attention to detail skills


For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322



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