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 / 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)
Promote quality as 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
Collaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing for process development projects
What Your Background Should Look Like:
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
Competencies: Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
About TE Connectivity TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future.
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