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Quality Assurance Specialist

hace 2 meses

Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo

Job Summary:

Thermo Fisher Scientific Inc. is seeking a highly skilled and experienced Quality Assurance Specialist to join our world-class team. As a Quality Assurance Specialist, you will play a critical role in ensuring the flawless quality of our products by collaborating closely with internal teams in Spain and Portugal and with PDX Quality.

Key Responsibilities:

  • Determine and implement Quality Assurance procedures to ensure flawless execution of projects
  • Collaborate with cross-functional teams to successfully implement quality improvement initiatives
  • Conduct thorough audits and inspections to ensure compliance with industry standards and regulations
  • Develop and maintain documentation of quality processes and procedures
  • Analyze data and identify areas for improvement to optimize operational efficiency
  • Train and educate team members on quality standards and effective strategies
  • Maintain the Quality Management System (QMS) as directed by the Quality Assurance at HQ, and the support of the Technical Director
  • Act as the Quality Management Representative / Subsidiary Quality management Representative for the company
  • Approves and monitors entries in the Nonconformance, Corrective Action/Preventive Action and training systems

Requirements:

  • Bachelor's degree in Life Sciences or a related field, or equivalent experience
  • Proven experience in quality assurance
  • Knowledge of Quality Management System requirements, especially with regard to European regulations (21 CFR Part 820, ISO13485/ IVDR and ISO9001 requirements)
  • Experience in medical device industry/Life Sciences industry experience preferred
  • Strong understanding of Quality Assurance methodologies and tools
  • Excellent analytical and problem-solving skills
  • Exceptional attention to detail and a commitment to delivering world-class results
  • Ability to work collaboratively in a fast-paced, ambitious environment