QUALITY MANAGER

Cologno Monzese, Lombardy, Italy About the job Newronika, a medical device spin-off company of two world’s leading neurological research institutes, opened a permanent position for a Quality Manager.
The Quality Manager will act as Management Representative of Quality and Person Responsible for Regulatory Compliance (PRRC).
The Quality Manager will be responsible for managing and continuously improving the Newronika quality management system (QMS), and will act as the point of contact with European Regulatory Agencies and Notified Bodies.
The Quality Manager will report to the Chief Technology Officer with a functional reporting line to the CEO.
The position is located in the Milan area in Italy.
Responsibilities.
To provide proactive leadership and strategic oversight to the quality function.
Hold overall responsibility for all duties fulfilled by the quality functions including quality assurance, internal and supplier auditing, CAPA, customer complaints, adverse event reporting, documentation control, quality control, supplier quality management To fulfil the role as person responsible for regulatory compliance, as required by Article 15 of the European MDR ().
To fulfil the role as management representative as required by clause 5.
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of ISO , ensuring that Top Management is informed of quality and customer issues or identified potential risks and that appropriate actions and resources are applied to quality and compliance concerns.
Chair and coordinate quality reviews and the annual management review of quality.
Maintain and promote continuous improvement of the QMS in accordance with internationally recognized quality standards and regulatory requirements which apply to Newronika.
Maintain awareness of current and new internationally recognized quality standards and regulatory requirements applicable to Newronika.
Work with internal staff, external suppliers and regulatory bodies to ensure quality processes meet regulatory and company guidelines.
Measure, monitor and evaluate the effectiveness of Quality Management System according to the company’s quality objectives.
Provide training in company quality policies and procedures to ensure the Quality Management System is understood and followed and quality awareness is promoted.
Qualifications.
Certificate or other evidence of formal qualification, awarded on completion of a university degree, in medicine, engineering or another relevant scientific discipline Minimum of 5 years’ experience in quality management systems, preferably relating to Medical Devices.
Excellent knowledge of ISO and 21 CFR 820.
Knowledge to the MDSAP audit approach will be advantageous.
Excellent knowledge of European regulations on Medical Devices, and the specific European guidelines (MEDDEVs and MDCG).
Experience in medical device software and clinical data management (for example, remote monitoring) Experience with European Notified Bodies and the US FDA.
Excellent English writing and presentation skills Able to work independently in a high-paced start-up environment.
Willing to travel (US, EU, Asia)   Contact.
Please email CV to Francesca Brambilla.