Quality Systems Analyst

hace 1 día


La Nava de Santiago, Badajoz, España Te Connectivity Corporation A tiempo completo
Job Overview

The Quality Systems Analyst / Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed according to the QMS procedures and must have a working knowledge of Quality Assurance and Quality Control.

Responsibilities:
  • Quality Systems Lead and Quality Representative for the site
  • Collaborate to ensure the relevance of the Quality Policy and the Quality Objectives
  • Work with Management to ensure that the proper resources are available to conduct QMS activities
  • Oversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions
  • Evaluate suppliers for ability to provide needed materials/services including supplier audits
  • Manage instrumentation and equipment used for inspections and V&V activities
  • Maintain records needed to demonstrate conformance to the 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 ensuring the most current revisions are available while segregating and storing previous revisions
  • Participate in the Internal Audit program
  • Acts as a Quality Representative during external audits (customer and notified bodies)
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
  • Must continually seek improvement and effect change in the operating systems
  • Ability to communicate effectively through email, instant messaging, and verbal methods
  • Ability to work individually and in a team environment
About Te Connectivity

Te Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future


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