A Career in Excellence
Job Summary: As a Senior Quality Engineer, you will champion continuous improvement initiatives and drive the CAPA system to reduce variation and improve performance.
Key Responsibilities Include:
* Review and Approve Crucial Documentation Including Validation Protocols and Reports (IQ, OQ, PQ) and Engineering Changes.
* Lead and Participate in Internal and External Audits to ISO 13485 and FDA Requirements, and Support Notified Body and Regulatory Agency Inspections.
* Lead Supplier Management and Qualification Activities, Including Maintaining the Approved Supplier List (ASL), Qualifying New Vendors Through Audits and Assessments, and Monitoring Supplier Performance via Scorecards.
Requirements: To be successful in this role, you will need strong technical skills and excellent communication abilities. You must have a proven track record of driving quality improvements and collaborating with cross-functional teams.
Benefits: In addition to a competitive salary and comprehensive benefits package, we offer opportunities for professional growth and development. Our team is dedicated to excellence, and we are looking for individuals who share our passion for delivering high-quality results.