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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, a leader in the medical device industry, is seeking a Senior Quality Systems Engineer with a strong focus on software validation and quality systems. This role offers the opportunity to contribute to groundbreaking healthcare innovations while ensuring compliance with stringent regulatory standards. Based in Athlone with a hybrid work model, this position is ideal for a professional eager to lead in the intersection of software and quality systems.

Responsibilities

  • Lead software validation processes for quality systems across the site.

  • Act as the primary point of contact for software lifecycle management and validation.

  • Develop, update, and maintain software-related risk assessments, validation protocols, and test methods.

  • Collaborate with cross-functional teams to integrate software solutions into quality systems.

  • Drive compliance with FDA and ISO 13485 standards for software applications.

  • Provide technical guidance for addressing CAPAs and non-conformances related to software systems.

  • Manage and document the software lifecycle using tools like JIRA, Qtest, and VERA.

  • Identify and implement process improvements in software validation and quality systems.

  • Support internal and external audits with a focus on software compliance and validation.

  • Guide engineering and quality teams in the implementation of robust software solutions.

Requirements

  • Bachelor’s degree (Level 8) or higher in Engineering, Science, or a related technical field.

  • Minimum of 5 years’ experience in software validation within regulated environments (medical devices preferred).

  • Strong knowledge of ISO 13485, FDA regulations, and software lifecycle processes.

  • Certification as a Lead or Internal Auditor (preferred).

  • Hands-on experience with software tools like JIRA, Qtest, VERA, Oracle, or similar platforms.

  • Familiarity with FactoryTalk, PEMAC, and Bartender systems is advantageous.

  • Proven ability to lead software-related quality investigations and implement corrective actions.

  • Expertise in creating and executing software validation documentation, including risk assessments and test plans.

  • Exceptional problem-solving and analytical skills in software and quality contexts.

  • Flexibility to work on-site 2-3 days per week in Athlone as part of a hybrid model.

Please get in touch with Cathal Herron for more information on these roles:

cathal.herron@collinsmcnicholas.ie

(090) 645 0660