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Quality Coordinator

  • Location: D15, Dublin, Ireland
  • Type: Permanent
  • Job #20372

Quality Coordinator

· 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.

BBBH 20372

Job Profile:

· 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

Benefits?

· 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!
OR
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Please don't hesitate to contact any of our team with any questions you may have on Email: info@allenrec.com or Phone: +353 1 6694040

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