Quality Assurance Specialist

hace 19 horas


Barcelona, Barcelona, España ThermoFisher Scientific A tiempo completo
Job Summary

Thermo Fisher Scientific Inc. is seeking a highly skilled Quality Specialist to ensure the flawless quality of our products. As a key member of our team, you will play a critical role in collaborating with internal teams and external partners to drive quality improvement initiatives.

Key Responsibilities:
  1. Develop and implement Quality Assurance procedures to ensure compliance with industry standards and regulations.
  2. Collaborate with cross-functional teams to successfully implement quality improvement initiatives and optimize operational efficiency.
  3. Conduct thorough audits and inspections to ensure compliance with quality management system requirements.
  4. Develop and maintain documentation of quality processes and procedures.
  5. Analyze data to identify areas for improvement and develop strategies to address them.
  6. Train and educate team members on quality standards and effective strategies.
  7. Maintain the Quality Management System (QMS) as directed by the Quality Assurance at HQ, and with the support of the Technical Director.
  8. Act as the Quality Management Representative / Subsidiary Quality Management Representative for the company.
  9. Approve and monitor entries in the Nonconformance, Corrective Action/Preventive Action, and training systems.
Requirements:
  1. Bachelor's degree in Life Sciences or a related field, or equivalent experience.
  2. Proven experience in quality assurance and regulatory compliance.
  3. Knowledge of Quality Management System requirements, especially with regard to European regulations (21 CFR Part 820, ISO13485/IVDR, and ISO9001 requirements).
  4. Experience in the medical device industry/Life Sciences industry preferred.
  5. Strong understanding of Quality Assurance methodologies and tools.
  6. Excellent analytical and problem-solving skills.
  7. Exceptional attention to detail and a commitment to delivering world-class results.
  8. Ability to work collaboratively in a fast-paced, ambitious environment.

Thermo Fisher Scientific Inc. is an equal opportunity employer and is committed to providing reasonable accommodations for individuals with disabilities. We value diversity and strive to create an inclusive and supportive work environment where all backgrounds and perspectives are respected.



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