· Our client is a multinational leader in the development of software products, remaining as one of the world’s top software and service providers with clients based in 42 countries globally.
· They are currently looking for a talented Quality Coordinator to join them in their Dublin office.
· The Quality Coordinator must have 2+ years of experience in a similar role and good understanding or exposure to GAMP 5 guidelines. They will be responsible for implementing and applying the principles and practices of software quality assurance throughout the software development lifecycle. This is an opportunity to join a rapidly growing and exciting Irish software company on permanent basis.
What does the Ideal Candidate look like?
· 2+ years of experience in a similar role
· An understanding or exposure to GAMP 5 guidelines;
· Knowledge of IEC62304 and ISO 13485 standards;
· Ability to implement the above standards and demonstrate compliance with FDA regulations
· Experience or understanding of software development cycle
What will the Quality Coordinator do?
· Generate quality control operating procedures and supply the necessary quality control data for submission to regulatory bodies
· Audit and analyse processes and procedures and perform GAP analysis
· Identify quality problems and recommend solutions
· Maintain the Quality Management System in a constant state of audit readiness
· Liaise with regulatory bodies including US FDA and HPRA
· Review and approve validation deliverables to ensure full compliance with Health Authority regulatory requirements and support its regulatory inspections
· Provide quality oversight in support of engineering, release and post-market support activities for:
o SaMD – Standalone software medical devices
o SiMD – Medical devices with embedded software
o Medical device infrastructure and internal hosting of product software
· Participate in audits and approve audit non-conformity action plans
· Demonstrate an understanding of many relevant Quality and Compliance principles and its applications
· Work collaboratively with project teams to keep them informed of project status, including any barriers, by assisting and driving status meetings to communicate and address project risks or issues
· Define internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
· Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
· 4 weeks’ holidays per annum.
· Light lunch daily – free canteen.
· Excellent working environment, including regular social events.
After six months of employment:
· Pension, Life assurance, Permanent Health, Insurance, Employee share scheme.
Still interested in this opportunity?
Submit your CV (in a Microsoft Word format) today!
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