(Only 24h Left) Quality Engineer- Software Validation

1 day ago


Longford, Ireland Collins McNicholas Recruitment Full time

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

1. Lead software validation processes for quality systems across the site.
2. Act as the primary point of contact for software lifecycle management and validation.
3. Develop, update, and maintain software-related risk assessments, validation protocols, and test methods.
4. Collaborate with cross-functional teams to integrate software solutions into quality systems.
5. Drive compliance with FDA and ISO 13485 standards for software applications.
6. Provide technical guidance for addressing CAPAs and non-conformances related to software systems.
7. Manage and document the software lifecycle using tools like JIRA, Qtest, and VERA.
8. Identify and implement process improvements in software validation and quality systems.
9. Support internal and external audits with a focus on software compliance and validation.
10. Guide engineering and quality teams in the implementation of robust software solutions.

Requirements

1. Bachelor’s degree (Level 8) or higher in Engineering, Science, or a related technical field.
2. Minimum of 5 years’ experience in software validation within regulated environments (medical devices preferred).
3. Strong knowledge of ISO 13485, FDA regulations, and software lifecycle processes.
4. Certification as a Lead or Internal Auditor (preferred).
5. Hands-on experience with software tools like JIRA, Qtest, VERA, Oracle, or similar platforms.
6. Familiarity with FactoryTalk, PEMAC, and Bartender systems is advantageous.
7. Proven ability to lead software-related quality investigations and implement corrective actions.
8. Expertise in creating and executing software validation documentation, including risk assessments and test plans.
9. Exceptional problem-solving and analytical skills in software and quality contexts.
10. 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

#J-18808-Ljbffr


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