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QUALITY ANALYST III


At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

The Quality Analyst is the Quality Representative for this location. The QA is responsible for ensuring that all quality related activities are being performed according the to the QMS procedures, and must have a solid working knowledge of ISO 13485 and FDA 21 CFR 820.  They must also be experienced in the medical device industry and have a strong background in device design & development and manufacturing.

 

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 for process development projects 
•    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
•    Manage the Internal Audits program 
•    Acts as the Quality Representative 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
•    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 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:

Education/Skills:


•    Bachelor’s Degree and minimum 5 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

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity

TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With more than 85,000 employees, including over 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Generous 401(k) Plan
  • Tuition Reimbursement
  • Benefits start on day one
  • Charity Donation Matching Program
  • Competitive Paid Time Off
  • Employee Resource Groups
  • Employee Stock Purchase Program
  • Healthcare for Associates and Families
  • Health and Wellness Incentives
  • Life Insurance and Disability Protection

Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.

 

EOE, Including Disability/Vets

Location: 

Carlsbad, CA, US, 92008

City:  Carlsbad
State:  CA
Country/Region:  US
Travel:  Less than 10%
Requisition ID:  86308
Alternative Locations: 
Function:  Quality


Nearest Major Market: San Diego

Job Segment: Document Control, CAPA, Instrumentation, QA, Administrative, Quality, Management, Engineering

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