Job Title: Senior Quality Systems Engineer
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.
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.