Quality Systems Analyst Inicio Inmediato
hace 7 días
**Job Summary**
The Quality Systems Lead is a critical role within Te Connectivity Corporation, responsible for ensuring the effective implementation and maintenance of our Quality Management System (QMS). This position requires a strong understanding of quality assurance and control principles, as well as excellent analytical and communication skills.
**Key Responsibilities:**
- Collaborate with management to ensure the relevance of the Quality Policy and Quality Objectives.
- Oversee Non-Conformance Reports (NCR), Complaint, and Corrective Action Preventive Action (CAPA) systems to ensure proper disposition of non-conforming materials and root cause determination.
- Evaluate suppliers for their ability to provide needed materials and services, including supplier audits.
- Manage instrumentation and equipment used for inspections and verification and validation (V&V) activities.
- 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.
**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.
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