Quality Assurance Specialist
hace 2 semanas
At TE Connectivity, we're committed to creating a safer, more sustainable, and connected world. As a Quality Systems Analyst, you'll play a critical role in ensuring our products meet the highest quality standards.
Job Summary:The Quality Systems Analyst is responsible for ensuring that all quality-related activities are performed according to our Quality Management System (QMS) procedures. This includes collaborating with management to ensure the proper resources are available to conduct QMS activities, overseeing non-conforming material disposition, root cause determination, and corrective/preventive actions, and evaluating suppliers for their ability to provide needed materials/services.
Key Responsibilities:- Collaborate with management to ensure the relevance of the Quality Policy and Quality Objectives
- Oversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions
- Evaluate suppliers for their ability to provide needed materials/services, including supplier audits
- 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 and 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
- 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
TE Connectivity is a global industrial technology leader committed to creating a safer, more sustainable, and connected world.
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