Medical Device Quality Engineer
Our client is a large medical device manufacturer. They manufacture a number of class 1, 2, and 3 medical devices. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering remediation support within new product innovations, and manufacturing.
Principle Duties and Responsibilities:
Looking for hands on support for the implementation of assurances, process controls, and CAPA systems designed to meet FDA requirements. They will assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Appropriately document risk management plans and design controls including protocol writing and reports. Lead the investigation, resolution and prevention of product and process non conformance.
The Quality Engineer (QE) is responsible in developing and implementing systems to ensure products are designed and produced to meet customer requirements and expectations. He/she drives the strategy and approach of the CAPA team to establish the root cause in a systematic way and coordinates the use of adequate tools and methods. Provides direction for the cross-functional team with other business and engineering disciplines to follow a structured problem solving approach. Establishes the principles of product and service quality evaluation and control for the system. Provides independent oversight and review of the project deliverables throughout the product life cycle. Provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same.
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
**This is NOT a lead role or managerial position, it requires hands on support in a very fast paced environment.
Job Type: Contract