Our client an indigenous Irish Medical Device company currently seeking a Senior Quality Systems Engineer. The Senior Quality Systems 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.

Role/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
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Good understanding of EN ISO 13485:2016, MDSAP and FDA regulations.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals
• Ability to interact professionally with all organizational levels
• Proficiency in use of desktop software applications such as MS office.
• Some travel will be required with the role.

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