Quality Systems Lead
hace 6 días
Job Summary
The Quality Systems Lead is responsible for ensuring that all quality-related activities are performed according to the QMS procedures. This role requires a working knowledge of Quality Assurance and Quality Control. The ideal candidate will have a strong background in quality management and excellent analytical skills.
Key Responsibilities
Collaborate with management to ensure 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
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
Participate in the Internal Audit program
Act 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
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
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. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more
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