Sector: Life Sciences
Consultant: Steven Jeffers
Salary: £61500 - £70300
Job Status: Permanent / Full Time
Our client an dynamic Dublin based company is looking to add to their current team, this is a fantastic opportunity for the right person and one that comes with great benefits and brilliant working enviroment.
The Quality Coordinator will be responsible for implementing and applying the principles and practises of software quality assurance throughout the software development lifecycle. The focus is on quality, so the individual must be meticulous and thorough, well organised and have good documentation skills.
- 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.
- 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 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.
The successful candidate must have
- An understanding or exposure to GAMP 5 guidelines
- Knowledge of IEC62304 and ISO 13485 standards
- Experience or understanding of software development cycle
- Ability to implement the above standards and demonstrate compliance with FDA regulations
- Proven documentation skills
- Excellent analytical and problem-solving skills
- Excellent IT Skills
- Outstanding communication skills
- Good interpretative and critical thinking skills.
If this sounds like you then click apply or email me your cv directly [email protected]