Quality Assurance Manager

Life Science Recruitment; Dublin; Hybrid; EUR 80,000 - 110,000; Full time

Job summary

Life Science Recruitment is supporting a specialty pharma company in Dublin City Centre, offering hybrid work. The Quality Manager and PRRC role focuses on QMS leadership, regulatory compliance, and partnership with authorities to ensure MDR and GDP standards are met.

The role requires experience with Medical Devices/MDR, MDSAP and ISO 13485, plus hands-on CAPA and audit coordination. Dublin-based, permanent position with hybrid working model.

Qualifications

• BSc in Life Science or related discipline.
• Experience working with Medical Devices and MDR knowledge.
• Knowledge of MDSAP, ISO 13485:2016, 21 CFR Part 820, GDP 2013/C343/01.

Responsibilities

• Maintain and manage the Quality Management System (QMS) and SOPs.
• Lead audits and manage supplier/CMO relationships; ensure audit-readiness across MDR/GDP.
• Perform PRRC duties per EU Article 15 for Medical Devices.
• Oversee MDR/GDP documentation, supplier evaluations, and post-market surveillance activities.
• Prepare annual management reviews and report KPI metrics for the Quality Department.

Skills

Quality management

Regulatory awareness

CAPA process

Audit coordination

GxP knowledge

Education

BSc in Life Science / related discipline

Tools

ETQ

Job description

Our client, a specialty Pharma company are currently recruiting for a Quality Manager and PRRC to join their team on a permanent basis. The role will primarily cover the management of quality systems for Medical Devices, as well as GDP Compliance for the Medicinal product. The role is based in Dublin City Centre with hybrid working.

Responsibilities:

Quality Management System

• Manage & maintain the Quality Management System (QMS)
• Create new SOPs and other quality documents
• Carry out risk assessments and manage change controls
• Manage the internal and external audit program and conduct and co-ordinate audits as required,
• including GDP Self inspections
• Organise, manage and monitor training via ETQ and maintaining training files
• Maintain the quality management system comprised of ETQ (document management system)
• documentation associated with company procedures ensuring audit-readiness at all times
• Handle complaints and processing post-marketing requirements for medical devices within the
• specified timelines - In support of the PRRC PMS activities
• Conduct corrective and preventative actions, oversee the CAPA log and report the
• progress of the CAPA at scheduled quality and annual management review meetings
• Manage warehouse including liaising with relevant company personnel ensuring receipt of
• regular inventory reports, addressing any storage excursion
• Act as the main point of contact with competent authorities and notified bodies
• Oversee the handling and maintain documentation supporting MDR, GDP, MDSAP and ISO standards
• Report to management on the effectiveness of the quality management system and any need for
• improvement
• Prepare and arrange the annual management review meetings
• Establish and review ongoing KPIs and objectives for the Quality Department
• Ensure the promotion of awareness of applicable regulatory requirements and quality
• management system requirements throughout the organisation
• Quality Agreement Management
• Progress the application for MDD to MDR transition for Class IIa Medical Device

Legal Manufacturer Activities - Medical Device

• Complete inspection of incoming raw materials
• Maintain up to date design and development document
• Complete final batch release approval including checks on batch documentation received from CMO
• Ensure the Technical Files are maintained and updated as required
• Lead supplier management activities including supplier evaluation and maintain an approved
• Act as point of contact within the Company for subcontracted activities carried out on behalf of the
• company, such as contracted manufacturing organisations (CMOs) and distributors
• Provide pro-active support for subcontractors strategically leading and directing to ensure key deliverables
• are achieved on time
• Develop and maintain a relationship with CMO’s to ensure a clear oversight of responsibilities assigned to subcontractors

PRRC - Carry out the require duties as per Article 15 of EU 2017/745, for various Medical Devices

• (Class I and Class IIa) including ensuring that:
• The conformity of the devices is appropriately checked, in accordance with the quality management
• system under which the devices are manufactured, before a device is released
• The technical documentation and the EU declaration of conformity are drawn up and kept up to date
• The Post Market Surveillance obligations are complied with in accordance with article 10(10)
• The reporting obligations referred to in Article 87 to 91 are fulfilled

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