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Quality Systems Lead
hace 2 meses
Job Overview
The Quality Systems Lead is a critical role at TE Connectivity, responsible for ensuring the effective implementation of quality-related activities across the organization. This position requires a strong working knowledge of Quality Assurance and Quality Control principles, as well as experience in managing quality systems and processes.
Key Responsibilities
- Collaborate with management to ensure the relevance of the Quality Policy and Quality Objectives, and provide guidance on quality-related matters.
- Oversee the Non-Conformance Report (NCR), Complaint, and Corrective Action Preventive Action (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 and services, including supplier audits and assessments.
- Manage instrumentation and equipment used for inspections and validation activities, ensuring they are properly calibrated and maintained.
- Maintain records and documentation to demonstrate conformance to quality standards and regulatory requirements.
- Conduct Quality Management Reviews to ensure the effectiveness of the Quality Management System (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 and act as a Quality Representative during external audits (customer and notified bodies).
- Promote a quality culture throughout the organization, working 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, ensuring that products meet quality and regulatory requirements.
Requirements
- Bachelor's Degree in a relevant field (Master's Degree preferred).
- Minimum 8 years of related work experience, with a strong background in quality assurance and quality control.
- Current working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820.
