- Burnsville, MN
The Supplier Quality Engineer II position implements and maintains the supplier management program in accordance with the internal quality management system and medical device regulations. This position works closely with development and manufacturing to provide technical support in the identification, selection, and qualification of suppliers. 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. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Primary individual working with Imricor suppliers to perform supplier audits, supplier onboarding, and supplier corrective actions.
- Conduct supplier quality system audits, ensuring timely and appropriate action is taken
- Performs analysis of incoming component defects. Dispositions and drives corrective action, as necessary. Communicates issues to suppliers.
- Coordinate resolution of supplier non-conformances including root cause investigation, corrective actions, and effectiveness evaluation
- Monitor, analyze and identify trends from supplier quality and performance data
- Define supplier quality specifications and sampling plans to evaluate and qualify suppliers per quality system.
- Reviews new design specifications and provides input from component quality and manufacturability perspective. Assists in generating product specifications related to outsourced components.
- Investigates field failures related to supplier products. Develop corrective action plan where necessary.
- Responsible for designing or specifying inspection and testing methods and procedures for component qualification, incoming inspection, and in-process inspection.
- Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
- Perform other related duties and responsibilities, as assigned
- Bachelor of Science in engineering, science, or technical field
- 2+ years Engineering and/or Quality experience.
- 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, ISO 13485.