QRC Manager Ireland

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

Job Title: QRC Manager Ireland

Home based in Republic of Ireland

Job Overview

QRC Manager IE responsible for maintaining and improving a compliant Quality Management System (ISO9001, ISO 13485), including audits, CAPAs, regulatory monitoring, product registrations, and ensuring adherence to quality and compliance targets, providing support to the QRC Regional Director. Acting as the Local Quality Manager (LQM) for Getinge Ireland according to the role within the QMS.  

Job Responsibilities and Essential Duties

Job responsibilities and essential duties split for Getinge Ireland as follows:

QMS

• Implementing and maintaining a compliant Quality Management System according to the corporate (Getinge) directives, ISO 9001 and ISO 13485.
• Ensuring the implementation of Quality Planning activities
• Act as the point of contact for all related questions to documentation management system, supporting the Irish sales and service organization with the implementation of the QMS as integral part of the operations
• Responsible for monitoring and maintaining quality and compliance targets, KPIs and objectives related to the QMS.
• Ensuring the availability of continuous training and supporting on the Quality Management Systems
• Responsible for and supporting the CAPA process within the UKI region
• Participating in internal and external audits and follow up on the audit findings, in cooperation with the QRC Director UKI
• Evaluate non-conformities and ensure implementation appropriate corrective/preventive actions
• Ensure Field actions and Quality holds are implemented
• Ensure complaints are reported in a timely manner and investigations performed for late reporting
• Responsible for maintaining supplier quality
• Ensure an effective Audit Program within the organization
• Cross collaboration with other QRC Regions and Areas to maintain and improve the Global Sales QMS.

Regulatory Affairs

• Ensuring that required importer and distributor checks are conducted according to EU MDR requirements
• Interact with the Authorities as a point of contact
• Organizing and contributing to inspections

Training & Communication

• Ensure training and awareness to the SSU’s in QMS / processes as required

KPIs (Key Performance Indicators)

• Monitor KPIs as defined by GET / GS objectives
• Implement QMS actions to achieve the defined targets •

Centre of Excellence

• Act as COE participant in the CAPA Center of Excellence within Global Sales and Service Organization
• Moderate and coordinate CAPA Review Boards (CRB)
• Support QRC Director with Global CAPA metrics and KPIs

General

• Providing back-up for QRC Director
• Supporting QRC Director with defining the vision for the region
• Communicating, escalating appropriate information
• Facilitate meetings with SSU

Minimum Requirements

• Bachelor degree in the field of medical technologies, business administration or related field experience.
• Minimum 5+ years hands-on experience in Quality & Regulatory
• Very good knowledge in Medical device regulation including, MDR, UKMDR, MDD, EUMDR and other local regulations
• Very good knowledge of ISO 13485 / ISO 9001
• Very good knowledge and experience of working with NCs and CAPAs
• Excellent language skills in English – verbal and written
• Experience performing both internal and supplier audits

Required Knowledge, Skills and Abilities

• Project management & risk analysis
• SharePoint, E-learning, TrackWise experience
• Customer oriented
• Results oriented
• Facilitation of meetings/training
• Development of indicators / dashboard

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.