QRC Specialist UKI (Medical Devices)

TL;DR

QRC Specialist UKI (Medical Devices): Maintaining and improving a compliant Quality Management System (ISO 9001, ISO 13485) with an accent on regulatory monitoring, product registrations, and audit management. Focus on ensuring adherence to MHRA requirements and managing corrective actions across the UK and Ireland.

Location: Remote (Must be able to work across the UK and Ireland)

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Maintain and control a Quality Management System based on ISO 9001, ISO 13485, and global procedures.
• Investigate non-conformities (NC) in tracking systems and follow up on corrective actions.
• Support and perform internal and external audits, including management of all related CAPAs.
• Monitor regulatory changes and ensure products are registered with the MHRA within deadlines.
• Manage complaint handling for the sales organization and implement Field Safety Corrective Actions (FSCA).
• Collect and monitor KPIs across the Quality Management System for Management Review.

Requirements

• Experience working with Quality Management Systems (QMS) is required.
• Knowledge of ISO 13485 and ISO 9001 standards.
• Ability to work effectively across the UK and Ireland.
• Excellent verbal and written English skills.

Nice to have

• Experience in the medical device industry.
• Knowledge of NC and CAPA processes.
• Experience with SharePoint, E-learning, or TrackWise.
• Knowledge of medical device regulations (MDR, UKMDR, MDD, and EUMDR).

Culture & Benefits

• Fully remote work arrangement (5 days at home).
• Professional and personal development opportunities in a diverse team.
• Opportunity to work with life-saving technology that makes a real difference for patients.
• Collaborative environment with global team interaction.