NeuroBell is a medical device company headquartered in Cork, Ireland, developing innovative solutions for improved brain monitoring for newborns. 0.5% of all newborns suffer brain injury and require brain monitoring to guide diagnosis and treatment to ensure the best possible outcome.
NeuroBell was initially funded through the Enterprise Ireland Commercialisation Fund programme and supported by +10 years of translational research at the INFANT Centre, University College Cork. NeuroBell has raised over €3m in public and private funding, led by two Venture Capital firms (Furthr VC and Atlantic Bridge). NeuroBell’s Cork office has +14 staff across engineering, science, regulatory and quality roles.
NeuroBell’s flagship product is the NeuroBell Luna, a pocket-sized & wireless electroencephalography (EEG) monitor for use in neonatal care, which provides automated neonatal seizure detection and a cloud-based web application for clinical review and reporting. NeuroBell Luna is currently in clinical trials across Ireland and the US.
About the Role:
NeuroBell is looking for a Quality Assurance Specialist to support the maintenance and audits of NeuroBell’s ISO 13485-certified Quality Management System (QMS) and to support the R&D department in preparing for regulatory submission and market approvals. The role is on-site at NeuroBell’s Cork office. The Quality Assurance Specialist will report to the Director of Quality & Regulatory Affairs. Specific duties include:
* Maintain and enhance the ISO 13485-certified Quality System as the company grows.
* Provides subject matter expertise as required across the organisation.
* Support R&D colleagues in Design Assurance tasks and documentation.
* Support regulatory submissions for market approval in the US and Europe.
* Support both internal and external audits/inspections.
* Participate as a key member of the team to R&D strategy and the long-term goal of developing market-leading solutions for neonatal brain monitoring.
About the Candidate:
The ideal candidate will be a keen problem-solver and eager to work alongside R&D colleagues in engineering, clinical, regulatory affairs. They must have clear attention to detail, enjoy fast-paced working environment, and thrive in taking responsibility for the development of effective products. They must be comfortable actively managing themselves and others to ensure quality compliance with company policies and procedures, including the identification and realisation of opportunities for improvement within the Quality System to ensure industry best practice and compliance.
Requirements:
* Knowledge of ISO 13485 and ISO 14971.
* Knowledge of regulatory pathways, including Design History File (DHF) and/or Technical File (TF) documentation, as per US and EU regulations.
* Experience of ISO 13485-compliant document control and change control procedures.
* Full driving licence
* Travel requirements: Candidates must be able to travel up to 10% of the time, with overnight stays as necessary to fulfil the role requirements.
Advantages:
* Experience participating/engaging in regulatory submissions for medical devices.
* Experience with IEC 60601: electrical medical devices and corresponding verification testing.
* Experience with IEC 62304: medical device software and corresponding documentation.
* Formal ISO 13485 internal and/or lead auditor training course completed.
Responsibilities:
* Contribute to ongoing ISO 13485 QMS activities and supporting internal and external audits.
* Contribute to the preparation of DHF and TF for regulatory submissions in US and EU.
* Support all the Senior Leadership team in achieving its goals of delivering safe and effective products.
* Deliver Quality Assurance related training as required.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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