Senior Quality Engineer

hace 2 semanas


Madrid, España Revvity A tiempo completo

Revvity is an international developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We have deep experience in our field, having been part of PerkinElmer’s 85-year history, and are excited for our future as a dedicated life sciences & diagnostics business. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity

**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.



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