Responsibilities: Work with commercial teams in different European locations to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices Distribution and Services, ISO9001, IVDR and other applicable regulatory and statutory requirements.
Serve as a bridge between commercial and manufacturing teams, providing timely visibility and solutions to quality issues that impact commercial operations.
Drive continuous improvement initiatives throughout the organization, fostering a culture of quality excellence and driving efficiency gains.
Coordinate, plan and manage audits (internal/cross-sites).
Facilitate external audit by certification body and support regulatory inspections by regulatory agencies.
Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures and regulatory requirements.
Establish, maintain and update relevant QMS documentation.
Coordinate the Quality Management Review meeting on a scheduled basis and prepare metrics and reports.
LMS administrative role for local procedure and practice.
Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation.
Support all Quality compliance and regulatory activities.
Requirements: Bachelor's Degree in science or engineering or quality fields.
Fluent English and at least one of the following languages: French, Spanish or Italian is mandatory, both spoken and written.
At least 3 years of experience in quality engineering, preferably in life sciences, pharmaceutical or healthcare industry.
Knowledge of Quality Management Systems (QMS) standards, including ISO9001, IVDR, and other applicable regulatory and statutory requirements.
Excellent problem-solving skills and attention to detail.
Excellent communication and interpersonal skills.
Ability to build strong relationships and engage internal stakeholders in QMS ownership, sensitive to working in a complex multinational environment.
Proficiency in Microsoft Office - advanced level.
Experience of ERP and CRM is advantageous.
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