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Quality Manager
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- Ireland
- Work type
- Hybrid
- Posted
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Quality Manager
Our client, a speciality Pharma company are currently recruiting for a Quality Manager to join
their team on a permanent basis. The role will primarily cover the management of quality systems for
Medical Devices. 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
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
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
Supplier Management
Lead supplier management activities including supplier evaluation and maintain an approved
vendor listing
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 CMOs 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:
BSc in Life Science / related discipline
Experience working with Medical Devices and knowledge of MDR
Knowledge of MDSAP, ISO CFR Part 820, GDP 2013/C343/01
For more information, please contact Sinéad Cullen on or
Our client, a speciality Pharma company are currently recruiting for a Quality Manager to join
their team on a permanent basis. The role will primarily cover the management of quality systems for
Medical Devices. 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
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
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
Supplier Management
Lead supplier management activities including supplier evaluation and maintain an approved
vendor listing
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 CMOs 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:
BSc in Life Science / related discipline
Experience working with Medical Devices and knowledge of MDR
Knowledge of MDSAP, ISO CFR Part 820, GDP 2013/C343/01
For more information, please contact Sinéad Cullen on or
Skills:
Quality Manager PRRC Quality Systems Manager
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