About this role
<p><img alt="" src="https://www.getinge.com/siteassets/start/company/careers/Global_careers-portal90126-small.jpg"></p> <p style="line-height:normal"> </p> <p style="line-height:normal"> </p> <p style="line-height:normal"><span style="font-size:18.0px"><span style="font-family:Arial, Helvetica, sans-serif"><b><span style="color:#18274a">With a passion for life</span></b></span></span></p> <p style="line-height:normal"> </p> <p style="line-height:normal"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">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. </span></span></span></p> <p style="line-height:normal"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">Are you looking for an inspiring career? You just found it.</span></span></span></p> <p style="line-height:normal"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;color:#182748">Location: Remote role with travel</span></strong></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;color:#182748">Job Overview</span></strong></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;color:#595857">QRC Specialist </span><span style="font-size:10.0pt;color:#595857">provides support to the QRC Director UKI 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.</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;color:#182748">Job Responsibilities and Essential Duties</span></strong></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;color:#595857">A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities:</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <ul> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Support in Maintaining and controlling a Quality Management System based on ISO9001, ISO 13485 and Global procedures</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Assisting in the investigation of NC handling in various tracking systems and following up on the corrective actions</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Assist in (FSCA) Field Safety Corrective Actions </span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Support and/or performing internal and external audits and support the QMS Manager with the follow up of these audits</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Support on all related CAPA’s and non-conformities</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Assisting in monitoring and maintaining quality and compliance targets</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Preparing and analysing information for the purpose of Management Review</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Stay alert on all regulatory changes, analyze the changes, and communicate, implement the applicable requirements</span></li> <li style="color:#595857;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Support in ensuring products are registered with the authorities (MHRA) within the required deadlines</span></li> <li style="color:#595857;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Assist in any Regulatory changes, analyse, communicate, anticipate and implement the applicable requirements</span></li> <li style="color:#595857;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Interact with the Authorities to provide requested feedback.</span></li> <li style="color:#595857;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Support the sales organisation with the complaint handling, ensure that the SSU’s are recording the complaints through the associated tools, within the time limits</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Supporting the implementation of Field actions and Quality Holds</span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Support and organise trainings and awareness to the SSU’s in Regulatory Affairs, Post-Market Surveillance, QMS </span></li> <li style="color:#595857;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt">Collecting and monitoring KPIs across the Quality Management System</span></li> </ul> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif;padding-left:40.0px"><strong><span style="font-size:10.0pt;color:#182748">Minimum Requirements</span></strong></p> <ul> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">A degree is desirable but not essential.</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Experience working with Quality Management System required</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Experience in the medical device industry is desirable</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Knowledge of ISO 13485 / ISO 9001</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Knowledge of NC and CAPA process desirable</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Excellent language skills in English – verbal and written</span></li> </ul> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Arial, sans-serif;padding-left:40.0px"><strong><span style="font-size:10.0pt;color:#182748">Required Knowledge, Skills and Abilities</span></strong></p> <ul> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Good knowledge of Microsoft packages</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">SharePoint, E-learning, TrackWise experience is desirable</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Knowledge in Medical device regulation (MDR, UKMDR), MDD and EUMDR is desirable</span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;color:#595857">Ability to work unsupervised / remotely </span></li> <li style="font-size:12.0pt;font-family:Arial, sans-serif;text-indent:3.6px"><span style="font-size:10.0pt;font-family:Arial, sans-serif;color:#595857">Ability to work well with others across UK and Ireland and other global locations</span></li> </ul><p> </p> <p><span style="font-size:14.0px"><b><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">About us </span></span></b></span></p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">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.</span></span></span></p> <p> </p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.</span></span></span></p>