Senior Quality Systems Engineer

1 week ago


Athlone, Ireland Collins McNicholas Full time

Our client is a global leader in the medical device industry, dedicated to developing innovative solutions that improve patient care and support healthcare professionals in delivering exceptional outcomes. They are seeking a Senior Quality Systems Engineer to join their team in Athlone, Co. Westmeath. This role offers an exciting opportunity to contribute to critical quality and compliance initiatives within a regulated environment. As a Senior Quality Systems Engineer, you will be instrumental in driving process improvements, leading audits, and ensuring regulatory compliance. The role is hybrid, with 2-3 days onsite. Responsibilities Represent the Quality function in site management meetings and act as a delegate for the Quality Lead when required. Lead quality systems software validation activities across the site. Drive process improvements and cost-saving initiatives using data analysis and quality tools. Develop and manage project plans, including resource allocation and technical activities such as procedural updates and test methods. Oversee risk documentation and process/software validation with significant business impact. Lead investigations into non-conformances (NCs) and corrective and preventive actions (CAPAs), providing technical guidance to teams. Ensure compliance with regulatory requirements, including ISO 13485 and FDA standards. Conduct internal and supplier audits and participate in external regulatory body audits. Collaborate with cross-functional teams to implement robust quality solutions. Provide guidance on quality and engineering processes to address compliance issues. Requirements Bachelors Degree or higher (Level 8) in Engineering or Science. Minimum of 5 years of experience in a regulated environment, ideally in the medical device sector. Demonstrated expertise in ISO 13485 and FDA regulatory environments. Certification as a Lead or Internal Auditor is an advantage. Please get in touch withCathal Herronfor more information on these roles: Skills: quality engineering quality systems qms



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