Quality Systems Analyst

hace 24 horas


Segovia, Segovia, España Te Connectivity A tiempo completo
Job Summary

We are seeking a highly skilled Quality Systems Analyst to join our team at Te Connectivity. As a Quality Systems Analyst, you will play a critical role in ensuring the effectiveness of our Quality Management Systems (QMS) and promoting a culture of quality throughout the organization.

Key Responsibilities
  • Collaborate with cross-functional teams to ensure the relevance of our Quality Policy and Quality Objectives.
  • Work with Management to ensure that the proper resources are available to conduct QMS activities.
  • Oversee Non-Conformance Reports (NCR), Complaint, and Corrective Action Preventive Action (CAPA) systems to ensure proper disposition of non-conforming materials and root cause determination.
  • Evaluate suppliers for their ability to provide needed materials and services, including supplier audits.
  • Manage instrumentation and equipment used for inspections and verification and validation (V&V) activities.
  • Maintain records needed to demonstrate conformance to standards.
  • Conduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirements.
  • Perform document control activities to ensure the most current revisions are available while segregating and storing previous revisions.
  • Participate in the Internal Audit program.
  • Act as a Quality Representative during external audits (customer and notified bodies).
  • Promote quality as a culture throughout the site and the organization.
  • Work collaboratively across site functions and with all levels of the organization.
  • Consult on new product development projects regarding quality-related questions and ensure that project documents are managed properly.
  • Support Verification & Validation and Design Transfer activities.
Requirements
  • Bachelor's Degree and minimum 5 years of related work experience (Master's Degree preferred).
  • Experience working in a team environment.
  • Current working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820 strongly preferred.
  • Strong MS Excel and Word experience.
  • Excellent analytical skills.
  • Ability to communicate effectively through email, instant messaging, and verbal methods.
  • Ability to work individually and in a team environment.
Competencies
  • Values: Integrity, Accountability, Inclusion, Innovation, Teamwork.


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