Quality Assurance Specialist

hace 2 semanas


Tijuana, Baja California, México Thermo Fisher Scientific A tiempo completo

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a key member of our quality team, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance in our medical device manufacturing operations.

Job Summary

The successful candidate will be responsible for monitoring, coordinating, and performing quality systems processes to sustain and improve quality systems. This will involve working closely with cross-functional teams to ensure that all quality-related activities are aligned with corporate objectives and industry standards.

Key Responsibilities

  1. Quality Systems Management: Develop, implement, and maintain quality systems processes to ensure compliance with ISO 9001 and ISO 13485 standards.
  2. Internal Audits: Coordinate and conduct internal audits to assess the effectiveness of quality systems and identify areas for improvement.
  3. External Audits: Support the preparation for external audits, including BSI and customer audits, to ensure compliance with regulatory requirements.
  4. Corrective Action: Manage and track corrective actions to ensure timely closure of non-conformities and prevent recurrence.
  5. Training and Development: Provide training and support to employees on quality-related topics to ensure awareness and understanding of quality systems.

Requirements

  • Education: Bachelor's degree in Engineering, Science, or equivalent experience.
  • Certifications: Internal Auditor Certification (ISO 9001:2015, ISO 13485:2016).
  • Experience: At least 2 years of experience in quality assurance or a related field in a medical device manufacturing company.
  • Skills: Strong analytical and problem-solving skills, excellent communication and leadership abilities, and proficiency in Microsoft Office.

About Us

Thermo Fisher Scientific is a leading global provider of scientific instrumentation, software, and services. We offer a competitive salary range of $80,000 - $110,000 per year, depending on experience and qualifications. In addition to a comprehensive benefits package, we offer opportunities for professional growth and development in a dynamic and supportive work environment.



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