Quality Systems Analyst
hace 2 días
Job Overview
The Quality Systems Analyst will be responsible for ensuring that all quality-related activities are being 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 understanding of ISO 13485 Quality Management Systems and FDA 21 CFR 820.
Responsibilities:
- Collaborate 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.
- 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.
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.
- 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.
About TE Connectivity
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future.
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