We are seeking a Quality Manager and PRRC to join our team on a permanent basis. The role will cover quality systems for Medical Devices and GDP Compliance for Medicinal products. The role is based in Dublin City Centre with hybrid working and occasional travel outside of Dublin required.
Responsibilities:
* Quality Management System
o Build and maintain the Quality Management System (QMS)
o Create new SOPs and other quality documents
o Carry out risk assessments and manage change controls
o Manage the internal and external audit program and conduct and co-ordinate audits as required
o Organise, manage and monitor training via ETQ and maintain training files
o Maintain the quality management system comprised of ETQ documentation associated with company procedures
o Handle complaints and process post-marketing requirements for medical devices
o Conduct corrective and preventative actions and oversee the CAPA log
o Manage warehouse and liaise with relevant company personnel
o Act as the main point of contact with competent authorities and notified bodies
o Oversee the handling and maintain documentation supporting MDR, GDP, MDSAP and ISO standards
o Report to management on the effectiveness of the quality management system
o Prepare and arrange the annual management review meetings
o Establish and review ongoing KPIs and objectives for the Quality Department
o Promote awareness of applicable regulatory requirements and quality management system requirements
* Legal Manufacturer Activities - Medical Device
o Complete inspection of incoming raw materials
o Maintain up to date design and development document
o Complete final batch release approval
o Ensure the Technical Files are maintained and updated as required
* Supplier Management
o Lead supplier management activities including supplier evaluation and maintain an approved vendor listing
o Act as point of contact within the Company for subcontracted activities
o Provide pro-active support for subcontractors
o Develop and maintain a relationship with CMOs
* PRRC
o Carry out the required duties as per Article 15 of EU 2017/745
o Ensure the conformity of devices is appropriately checked
o Draw up and keep up to date technical documentation and EU declaration of conformity
o Comply with Post Market Surveillance obligations
o Fulfill reporting obligations referred to in Article 87 to 91
Requirements:
* Meet the regulatory requirements of a PRRC
* BSc in Life Science / related discipline
* Experience working with Medical Devices and knowledge of MDR
* Knowledge of MDSAP, ISO 13485:2016, 21 CFR Part 820, GDP 2013/C343/01