With a passion for life, we invite passionate people to join our diverse teams and develop both personally and professionally. Getinge exists to make life‑saving technology accessible to more people. To make a true difference for our customers – and to save more lives – we need team players, forward thinkers and game changers.
Location: Remote role with travel
Job Overview
The QRC Specialist supports the QRC Director UKI in maintaining and improving a compliant Quality Management System (ISO9001, ISO13485), including audits, CAPAs, regulatory monitoring, product registrations, and ensuring adherence to quality and compliance targets.
Responsibilities
- Support in maintaining and controlling a Quality Management System based on ISO9001, ISO13485 and Global procedures
- Assist in the investigation of NC handling in various tracking systems and follow up on corrective actions
- Assist with Field Safety Corrective Actions (FSCA)
- Support and/or perform internal and external audits and support the QMS Manager with audit follow‑up
- Support all related CAPAs and non‑conformities
- Assist in monitoring and maintaining quality and compliance targets
- Prepare and analyse information for Management Review
- Stay alert on all regulatory changes, analyse them and communicate/implement applicable requirements
- Support ensuring products are registered with the authorities (MHRA) within required deadlines
- Assist in any regulatory changes, analyse, communicate, anticipate and implement applicable requirements
- Interact with the authorities to provide requested feedback
- Support the sales organisation with complaint handling, ensuring SSUs record complaints within time limits
- Support implementation of field actions and quality holds
- Support and organise trainings and awareness for SSUs in Regulatory Affairs, Post‑Market Surveillance, QMS
- Collect and monitor KPIs across the Quality Management System
Minimum Requirements
- A degree is desirable but not essential
- Experience working with a Quality Management System
- Experience in the medical device industry is desirable
- Knowledge of ISO13485 / ISO9001
- Knowledge of NC and CAPA processes desirable
- Excellent language skills in English – verbal and written
Required Knowledge, Skills and Abilities
- Good knowledge of Microsoft packages
- SharePoint, e‑learning, TrackWise experience desirable
- Knowledge in medical device regulation (MDR, UKMDR), MDD and EUMDR desirable
- Ability to work unsupervised / remotely
- Ability to work well with others across UK, Ireland and other global locations
About Us
Getinge believes that every person and community should have access to the best possible care. We provide hospitals and life science institutions with products and solutions that improve clinical results and optimise workflows. Our product portfolio includes solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and sells to more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
#J-18808-Ljbffr
QRC Specialist UKI employer: Getinge
Getinge Group is an exceptional employer that prioritises the well-being and professional growth of its employees. With a strong commitment to work-life balance, competitive benefits including private healthcare and a clear progression pathway, Getinge fosters a supportive and collaborative work culture. As a Field Service Engineer, you will not only have the opportunity to make a meaningful impact in the medical field but also enjoy the unique advantage of working with cutting-edge technology while being part of a team that values innovation and sustainability.
