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AI Summary
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.
Location: Remote role with travel
Job Overview
QRC Specialist 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.
Job Responsibilities and Essential Duties
A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities:
- Support in Maintaining and controlling a Quality Management System based on ISO9001, ISO 13485 and Global procedures
- Assisting in the investigation of NC handling in various tracking systems and following up on the corrective actions
- Assist in (FSCA) Field Safety Corrective Actions
- Support and/or performing internal and external audits and support the QMS Manager with the follow up of these audits
- Support on all related CAPA’s and non-conformities
- Assisting in monitoring and maintaining quality and compliance targets
- Preparing and analysing information for the purpose of Management Review
- Stay alert on all regulatory changes, analyze the changes, and communicate, implement the applicable requirements
- Support in ensuring products are registered with the authorities (MHRA) within the required deadlines
- Assist in any Regulatory changes, analyse, communicate, anticipate and implement the applicable requirements
- Interact with the Authorities to provide requested feedback.
- 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
- Supporting the implementation of Field actions and Quality Holds
- Support and organise trainings and awareness to the SSU’s in Regulatory Affairs, Post-Market Surveillance, QMS
- Collecting and monitoring KPIs across the Quality Management System
Minimum Requirements
- A degree is desirable but not essential.
- Experience working with Quality Management System required
- Experience in the medical device industry is desirable
- Knowledge of ISO 13485 / ISO 9001
- Knowledge of NC and CAPA process desirable
- Excellent language skills in English – verbal and written
Required Knowledge, Skills and Abilities
- Good knowledge of Microsoft packages
- SharePoint, E-learning, TrackWise experience is desirable
- Knowledge in Medical device regulation (MDR, UKMDR), MDD and EUMDR is desirable
- Ability to work unsupervised / remotely
- Ability to work well with others across UK and Ireland and other global locations
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.
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