Senior Commercial Quality Engineer

hace 1 semana


Madrid, Madrid, España Revvity A tiempo completo

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/crosssites).
  • 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 problemsolving 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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