International group of companies, providing innovation within the medical device field to improve patient mobility and accessibility. With manufacturing sites located throughout the UK and Europe, and sales functions globally, they hold a strong market share, with further growth plans.
As Quality Manager, you will act as Management Representative, conducting all internal audits, CAPA management, and compliance for all QARA functions. Based in Yorkshire, some additional travel will be required across the UK.
- Ensure all processes needed for the Quality Management System (QMS) are documented
- Reporting to Management on the effectiveness of the QMS and any need for improvement
- Ensuring the promotion of awareness of applicable Regulatory and QMS requirements
- Develop and implement robust manufacturing processes to ensure final products are safe, and meet customer expectations, while keeping the manufacturing process as effective and cost-efficient as possible
- Plan, perform and report internal audits in accordance with ISO13485 and company procedures across multiple sites
- Administration and management of site QMS CAPAs (Track, monitor, advise, review/validate, approve, and perform VoE checks)
- Lead QMS CAPA meetings with relevant stakeholders
- Train relevant stakeholders in Root Cause and Corrective Action methods and techniques.
- Ensure application, monitoring and reporting of Group QMS (as site level)
- Prepare data for management review meetings
- Hold local, interim QMS reviews to assess its suitability, adequacy and effectiveness (pre-management review)
- Plan, perform and report supplier audits
- Manage key supplier CAPA program
- Working with various stakeholders in the manufacturing process such as design teams, suppliers, manufacturing teams, and customers.
- Support the Management Representative in their core responsibilities including data analysis and Certification Body / customer audit hosting
- Assist in the creation, review and approval of controlled documents
- Assist in preparation of monthly Quality Report and associated dashboard
- Support creation and monitoring of Group Quality Objectives
- Support continual improvement projects as required by Line Manager
Requirements / Qualifications
- Recent, practical experience of Quality Management systems, ideally ISO13485
- Competent and trained internal auditor (Ideally certified internal auditor / lead auditor to ISO13485)
- Practical application of Observe, Plan, Do, Check, Act cycle (OPDCA)
- Working knowledge of MDD (93/42/EEC) and MDR (2017/745)
- General knowledge of medical device regulatory affairs framework
- Full, clean driving licence
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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