Senior Commercial Quality Engineer
Il y a 2 mois
**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.
- 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 scheduled basis and prepares 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 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.
- Availability to start in May/ June
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