Responsibilities:
Create and maintain Quality Plan for the Supplier Control Improvement Project
Perform activities that will qualify suppliers per improved procedures and monitor current supplier base to ensure the status of the suppliers is correct.
Work with suppliers as needed to ensure their performance is acceptable per site requirements.
Work with Design and Development Teams when qualifying new suppliers and monitoring of supplier performance.
Provides technical support in the selection of suppliers. Develops acceptance criteria for materials.
Analyze Supplier information and present Supplier metrics to Management Reviews.
Responsible for writing and maintaining Standard Operating Procedures related to Supplier Controls and Incoming Inspection.
Provides technical support in the selection of suppliers. Develops acceptance criteria for materials.
Maintains Approved Supplier List, Supplier Reevaluation and Documentation Review Schedule and Approved Part List
Support the continuous improvement to the Quality Management System, with a specialty focus on Supplier Controls.
Assist with internal and external audits.
Perform any other assigned responsibility.
BASIC QUALIFICATIONS | EDUCATION:
Minimum BA/BS in science, engineering or health-related discipline.
Minimum 3 years' experience working in Quality Department in a medical device environment related to Supplier Quality.
Experience with Quality Project Management required.
Independently lead the project with minimum direction.
A thorough understanding of the ISO 13485 standard, ISO 14971 standard and FDA Regulations and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
Must be able to work effectively in a cross-functional environment, achieving compliance though teamwork, facilitation, and influence.
Must have demonstrated written and verbal communication skills, including ability to articulate complex arguments with clarity.