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Senior Quality Systems Engineer

  • Location: County Westmeath
  • Job Type:Permanent
  • Sector: Engineering
  • Contact Email: cathal.herron@collinsmcnicholas.ie
  • Job Ref: 23717

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

  • Bachelor’s 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 with Cathal Herron for more information on these roles:

cathal.herron@collinsmcnicholas.ie

(090) 645 0660