QRC Specialist UKI
Remote
Job Summary
Maintain and control a Quality Management System based on ISO9001 and ISO13485 standards, including audits, CAPAs, and regulatory monitoring. Investigate non-conformities in tracking systems, support Field Safety Corrective Actions, and ensure product registrations with authorities like MHRA meet deadlines. Monitor quality targets, prepare information for Management Review, and stay alert to regulatory changes to implement applicable requirements. Interact with authorities, support complaint handling, organize training for SSUs, and collect KPIs across the QMS. This remote role with travel supports the QRC Director UKI within Getinge, a global leader in life-saving technology for hospitals and life science institutions.
Required Qualifications
- Experience working with Quality Management System
- Knowledge of ISO 13485 / ISO 9001
- Knowledge of NC and CAPA process
- Excellent language skills in English – verbal and written
- Good knowledge of Microsoft packages
- Ability to work unsupervised / remotely
- Ability to work well with others across UK and Ireland and other global locations
Desired Qualifications
- A degree is desirable but not essential
- Experience in the medical device industry
- SharePoint, E-learning, TrackWise experience
- Knowledge in Medical device regulation (MDR, UKMDR), MDD and EUMDR
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