Quality Analyst II

Job Overview

TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

Responsibilities:

• Consult on new product development projects regarding quality related questions and ensure that project documents are managed properly
  
• Support V&V and Design Transfer activities
  
• Collaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing criteria for process development and manufacturing projects
  
• Assist in preparation for Quality Management Reviews and other activities periodically to ensure the effectiveness of the QMS in accordance with ISO 13485 standards, FDA regulations, and/or other applicable regulatory requirements
  
• Support the Internal Audits program as an integral Internal Audit Team member
  
• Support the Quality Managers and Quality Representative(s) during external audits
  
• 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
  
• Manage NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root-cause determination, and corrective/preventive actions and report any issues/concerns to Management
  
• Evaluate suppliers for ability to provide needed materials/services and help manage the ASL (including supplier audits as needed)
  
• Manage instrumentation and equipment used for inspections and V&V activities
  
• Maintain records needed to demonstrate the conformance to the standards
  
• Promote quality as culture throughout the site and the organization
  
• Work collaboratively across site functions and with all levels of the organization
  

What your background should look like:

• Bachelor’s Degree and minimum 3 years of related work experience
  
• Experience working in a team environment where few others are experts in quality systems
  
• Current working knowledge of ISO 13485 Quality Management System and FDA 21 CFR 820
  
• Strong MS Excel and Word experience
  
• Excellent accuracy and 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
  

Competencies