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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 being performed according to the QMS procedures and must have a working knowledge of Quality Assurance and Quality Control. Candidates from all industries are invited to apply.
Responsibilities:
1. Quality Systems Lead and Quality Representative for the site
2. Collaborate to ensure the relevance of the Quality Policy and the Quality Objectives
3. Work with Management to ensure that the proper resources are available to conduct QMS activities
4. Oversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions
5. Evaluate suppliers for ability to provide needed materials/services including supplier audits
6. Manage instrumentation and equipment used for inspections and V&V activities
7. Maintain records needed to demonstrate conformance to the standards
8. Conduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirements
9. Perform document control activities ensuring the most current revisions are available while segregating and storing previous revisions
10. Participate in the Internal Audit program
11. Acts as a Quality Representative during external audits (customer and notified bodies)
12. Promote quality as culture throughout the site and the organization
13. Work collaboratively across site functions and with all levels of the organization
14. Consult on new product development projects regarding quality related questions and ensure that project documents are managed properly
15. Support Verification &Validation and Design