Quality Coordinator- Hybrid Dublin/Remote

Job Overview

Quality Coordinator - Hybrid Work (Dublin and Remote)

This well-established and highly regarded software platform is actively recruiting a Quality Coordinator to join their growing team - Hybrid - (Dublin and Remote)

This company in Dublin 15 have a superb working environment and the company invest heavily in developing and training their employees.

In your new role as Quality Coordinator you will be responsible for applying the protocols and practises of software quality assurance throughout the software development lifecycle. You must be meticulous and thorough, well organised and have good documentation skills.

Duties

  • 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 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
  • The approval of lifecycle/design controls documentation and deliverables, including the approval to release system implementation and/or changes for production use
  • Provide quality oversight in support of engineering, release and post-market support activities for:

SaMD - Standalone software medical devices

SiMD - Medical devices with embedded software

  • 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 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

Requirements

  • 2-3 years of experience in a similar Quality role, working with ISO 13485 standards , experience with IEC62304 is desirable
  • An understanding or exposure to GAMP 5 guidelines
  • Experience or understanding of software development cycle
  • Ability to demonstrate compliance with FDA regulations
  • Excellent documentation skills
  • Superior Analytical and problem-solving and communication skills
  • IT Skills
  • Good interpretative and critical thinking skills

This really is a fantastic opportunity to join a large, highly regarded software platform. For immediate consideration, apply with your CV asap.

Keywords: ISO 13485, GAMP, Software Development Lifecycle, Audits, Quality, Quality Control, Quality Assurance

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