Quality Systems Analyst

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable, and more connected world.

Job Overview

The Quality Analyst / Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are performed according to the QMS procedures. Candidates from all industries are invited to apply.

Responsibilities:

1. Serve as the Quality Systems Lead and Quality Representative for the site.
2. Collaborate to ensure the relevance of the Quality Policy and Objectives.
3. Work with Management to ensure resources are available for QMS activities.
4. Oversee NCR, Complaint, and CAPA systems for proper disposition of non-conforming materials, root cause analysis, and corrective/preventive actions.
5. Evaluate suppliers' ability to provide needed materials/services, including conducting supplier audits.
6. Manage instrumentation and equipment used for inspections and V&V activities.
7. Maintain records demonstrating conformance to standards.
8. Conduct Quality Management Reviews to ensure QMS effectiveness in accordance with ISO 13485 and regulatory requirements.
9. Perform document control activities, ensuring current revisions are available and previous revisions are stored properly.
10. Participate in the Internal Audit program.
11. Represent quality during external audits (customer and notified bodies).
12. Promote a quality culture throughout the site and organization.
13. Collaborate across functions and levels within the organization.
14. Consult on new product development regarding quality questions and document management.
15. Support Verification & Validation and Design Transfer activities.
16. Collaborate with manufacturing/operations on inspections and testing for process development projects.

Qualifications:

1. Bachelor’s Degree with at least 5 years of related experience; Master’s Degree preferred.
2. Experience working in a team environment.
3. Knowledge of ISO 13485 and FDA 21 CFR 820 is strongly preferred.
4. Proficiency in MS Excel and Word.
5. Excellent analytical skills.
6. Ability to seek continuous improvement and implement changes.
7. Effective communication skills via email, messaging, and verbal methods.
8. Ability to work independently and collaboratively.

Core Competencies: Integrity, Accountability, Inclusion, Innovation, Teamwork

What TE Connectivity Offers:

• Competitive salary package.
• Employee Resource Group.
• Benefits supported by TE or external providers, varying by site.