This is a leading innovative Medical Devices organisation that is focussed on the development of cutting edge technologies for the measurement and interpretation of the progression of debilitating brain disorders. This organisation's machine learning powered digital health platform allows this business to rapidly build the worlds largest collection of real-world brain activity and cognitive health data. The insights this organisation's technologies develops helps transform our understanding of brain health and improves the development of novel treatments for brain disorders. Currently, this organisation is now entering a growth phase in this businesses history and due to this expansion, this organisation are looking for a strong Quality professional to join the business and lead all Quality functions for the business.
In this leadership role as Director of Quality, you will report directly to the CEO and be responsible for overall company strategy for quality and compliance, along with maintenance, development and certification of the ISO 13485-based Quality Management System (QMS) and supporting quality obligations of the organisation with a focus on digital health products for use in clinical trials. You will ensure the organisation undertakes all operational activities in accordance with the necessary operational standards, guidelines and good clinical practice.
- Develop and implement a quality and regulatory strategy for a digital health and medical device platform for use in clinical trials in the US, UK and EU markets.
- Manage and grow the Quality group with a matrix of internal staff and external contract team members.
- Maintain, develop and support certification of the Quality Management System (QMS) supporting use of the technology, which includes internally developed systems and integrated external third party SaaS systems, in global clinical trials and as a medical device.
- Define and implement risk assessment procedures in accordance with appropriate standards and regulations.
- Establish and implement quality improvement and trend analysis procedures, defining metrics, KPI and trend tracking.
- Manage supplier selection, agreements, audits and compliance.
- Be the management representative for all external audits and inspections, and responsible for planning and coordinating internal audits.
- BSc in Engineering, Sciences or equivalent, or Certified Quality Engineer (CQE).
- 15+ years in a quality role with 4+ years of experience as a QA Manager at a medical device, digital health tech, or clinical research organisation.
- Expertise with global quality system standards for medical devices (ISO 13485, MDSAP, MDD, MDR, 21 CFR 820), application of risk management (ISO 14971) and risk assessment activities including risk assessment and risk analysis, cybersecurity standards for IT-networks/cloud based systems (ISO 27001/PD IEC/TR 80001-2-2) and medical devices (UL 2900-1)
- Expertise with computer system validation to US and EU standards including electronic records, signatures and the use of computerised systems in clinical investigations (CFR 21 part 11/EU Annex 11, GCP and ICH guidelines).
- Expertise with standards such as medical device (IEC 60601) and device software (IEC 62304, SaMD, and FDA GPSV) with a strong focus on end-user usability (IEC 62366).
- Expertise with digital and wearable medical device systems and the guidelines and quality standards for their development and use in clinical trials including electronic patient reported outcomes (ePRO) and electronic clinical outcome assessment (eCOA) tools.
- Familiarity with regional data protection regulations and standards (GDPR, HIPAA).
- Comfortable working in a high growth / start up environment.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.