Quality Manager
MálagaOn-site
AI Summary
The Quality Manager leads and maintains the Quality Management System (QMS) for assigned laboratory(s), ensuring compliance with ISO 9001, regulatory, and customer requirements. They drive quality improvements, manage incidents and audits, and act as key liaison with certification bodies and regulatory authorities.
About this role
The Quality Manager is responsible for the Quality programs, systems, processes and procedures and that the performance and quality of services conform to established regulatory and accreditation requirements within the laboratory(ies) of the assigned area(s).
Key Responsabilities
- Lead and maintain the Quality Management System (QMS), ensuring compliance with ISO 9001, customer requirements, and applicable regulatory standards.
- Promote a culture of quality across the organisation through training, SOP implementation, communication, and continuous education on quality management principles and tools.
- Develop, monitor, and report quality objectives and improvement initiatives in collaboration with Group and local leadership teams.
- Manage quality-related incidents, non-conformities, complaints, adverse events, and post-market surveillance activities, including risk assessments, root cause analysis, corrective actions, and regulatory reporting.
- Plan, lead, and coordinate internal and external audits, certification activities, management reviews, and follow-up actions to ensure ongoing compliance and continuous improvement.
- Act as the key liaison between radiology institutes, certification bodies, regulatory authorities, and internal stakeholders on all quality and compliance matters.
- Drive process harmonisation, risk management, business continuity, and quality improvements through KPIs, dashboards, change controls, and implementation of corrective and preventive actions.
- Support operational and medical management teams with quality-related activities, governance, budget management, and regulatory compliance initiatives.
Personal and professional attributes
- Excellent interpersonal, organizational & communication skills with excellent attention to detail.
- Ability to influence and affect change.
- Rigorous, organized, autonomous.
- Ability to work independently and initiate contacts as necessary
- Responsive problem solver and action oriented.
- Able to work effectively under pressure.
- Time flexibility and travelling.
Requirements
- Master’s Degree in a technical/ process engineering/QA discipline, Advanced Degree preferred, with significant related professional experience within the healthcare environment.
- Operational experience in the field of Radiology.
- Fully versed in ISO 9001, 14001 and Risk Management.
- Demonstrated in-depth knowledge in quality process mapping and development.
- English fluent as a must (presenting, writing, reading).
- Minimum Years Recommended and/or Preferred in a manager role: 3 years
Skills
Continuous ImprovementCorrective And Preventive Actions (CAPA)Healthcare Quality ComplianceInternal AuditsISO 14001ISO 9001Laboratory Quality SystemsProcess MappingQMSRisk Management
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