Job Title: Quality Manager / PRRC
We are seeking a Quality Manager and PRRC to join our team on a permanent basis. The role will primarily cover the management of quality systems for Medical Devices, as well as GDP Compliance for Medicinal products.
The successful candidate will be based in Dublin City Centre with hybrid working. Occasional travel outside of Dublin may be required.
Responsibilities:
* Manage and maintain the Quality Management System (QMS), including creating new SOPs and other quality documents.
* Carry out risk assessments, manage change controls, and conduct internal and external audits as required.
* Organise, manage, and monitor training via ETQ and maintain training files.
* Maintain the quality management system comprised of ETQ documentation associated with company procedures ensuring audit-readiness at all times.
* Handle complaints and processing post-marketing requirements for medical devices within specified timelines.
* Conduct corrective and preventative actions, oversee the CAPA log, and report progress at scheduled quality and annual management review meetings.
* Manage warehouse operations, including liaising with relevant personnel to ensure receipt of regular inventory reports and addressing storage excursions.
* Act as the main point of contact with competent authorities and notified bodies.
* Oversee handling and maintaining documentation supporting MDR, GDP, MDSAP, and ISO standards.
Requirements:
* Meet regulatory requirements of a PRRC.
* Bachelor's degree in Life Science or related discipline.
* Experience working with Medical Devices and knowledge of MDR.
* Knowledge of MDSAP, ISO 13485:2016, 21 CFR Part 820, and GDP 2013/C343/01.
Estimated Salary: €60,000 - €80,000 per annum, depending on experience and qualifications.