Senior Supplier Quality Engineer

Imricor Medical Systems Inc•Burnsville, MN

10d•$100,000 - $130,000

About The Position

The Senior Supplier Quality Engineer position implements and maintains the supplier management program in accordance with the internal quality management system and medical device regulations. This position works with both development and manufacturing to provide technical support in the identification, selection, and qualification of suppliers and components. This position is responsible for monitoring and managing supplier performance throughout the product development cycle. This position will monitor supplier performance and drive improvement and corrective action in the quality of components sourced from outside suppliers related to manufacturing and field issues. Additionally, this position is responsible for adhering to the Imricor Quality Management System requirements and fulfilling duties as outlined in the environmental, health, and safety policies.

Requirements

Bachelor of Science in engineering, science, or related technical field.
5+ years of Engineering and/or Quality experience. Medical Device experience preferred.
Experience with Microsoft Office: Word, Excel, PowerPoint.
Knowledge of basic Quality Systems and good documentation practices.
Knowledge of FDA, GMP, and ISO regulations; experience with auditing, and quality system implementation preferred. Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, and ISO 13485 preferred.

Nice To Haves

Medical Device experience
Experience with auditing, and quality system implementation
Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, and ISO 13485

Responsibilities

Is the primary role that works with Imricor suppliers to perform supplier selection and qualification, component qualification, supplier monitoring, and supplier corrective actions.
Drives supplier selection and qualification activities by interfacing with external suppliers to generate and review supplier surveys, quality agreements, nondisclosure agreements, and other supplier qualification documentation.
Conducts supplier quality management system audits both virtually and in-person.
Is responsible for successful completion of component qualification activities including review and development of purchased product specifications, collaboration with suppliers, determination of component qualification deliverables and acceptance criteria, and analysis of results.
Develops receiving inspection plans and associated test method development activities.
Monitors, analyzes, and identifies trends from supplier quality and performance data. Drives necessary supplier performance improvement.
Performs analysis of purchased product nonconformances and supplier-related field quality issues. Communicates issues to suppliers and oversee subsequent corrective action implementation and evaluation.
Guides organization on supplier policy by leading CAPAs and other quality system initiatives.