We are a leading diagnostics company seeking an experienced Quality Manager to join our team. This role will be responsible for maintaining and developing our Quality Management System while ensuring regulatory compliance across our diagnostic operations in the UK and ROI.
This is a key leadership role working closely with senior management to drive quality excellence, regulatory compliance, and continuous improvement across the organisation.
Key Responsibilities
* Maintain and develop the Quality Management System (QMS) and ensure continued ISO9001 certification
* Ensure ongoing compliance with regulatory requirements and applicable legislation
* Act as Management Representative for the quality system
* Lead internal audits and support external audit programmes
* Manage the Management Review process and report on QMS performance
* Lead CAPA activities, root cause investigations, and corrective actions
* Monitor and report on non-conforming products and market quality issues
* Drive continuous improvement initiatives based on operational data and customer feedback
* Oversee the Quality Surveillance programme
* Act as Q-Pulse System Administrator including documentation, CAPA, audits and COSHH management
* Lead New Product Introduction (NPI) quality processes
* Work cross-functionally with internal teams, suppliers and customers on quality matters
* Provide quality awareness training and promote a culture of quality across the organisation
Skills & Experience
* Degree or equivalent qualification
* Strong understanding of the medical device or diagnostics industry
* Excellent knowledge of ISO9001, ISO13485 and ISO17025
* Strong analytical and problem-solving skills with high attention to detail
* Excellent organisational and time management skills
* Strong interpersonal and stakeholder management abilities
* Ability to work both independently and collaboratively across teams
* Excellent written and verbal communication skills
* High level of integrity and professional ethics
What We’re Looking For
We are looking for a proactive and solution-focused Quality professional who can lead quality initiatives, influence stakeholders, and drive continuous improvement across the business.
The successful candidate will be highly organised, collaborative, and comfortable working in a fast-paced operational environment.
To apply - please apply via this advert! Look forward to receiving your applications!
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