Sr. Qualtity Engineer in Medford, MA

Provides oversight of design control activities, design and technology transfer to manufacturing, risk management program and process validation activities. Coordinates overall quality activities for product development programs/projects, ensuring compliance with WWQA standards, AGM Design Control and Risk Management SOPs, and regulatory qualifications (CFR 820, ISO 13485, ISO 1497). Provides quality engineering guidance to product development teams throughout the product development process to ensure appropriate PDP deliverables, resulting in the development of safe and effective medical devices. Job descriptionThis position has full responsibility and accountability to act and make decisions in the respective position qualifications. Provides oversight of R&D new product programs/projects as it relates to design and development, technology transfer, and process validations. Serves as the Quality representative on all R&D programs/projects. Utilizes Design for 6 Sigma methodology/tools to promote a disciplined approach to product and process design in order to ensure product quality and process capabilities. Reviews and approves product and equipment specification such as User, Functional and Design Qualifications. Reviews and approves change control activities associated with R&D design, processes and equipment changes. Provide Risk Management strategy for the design and development of new products to meet regulatory qualifications. Engages in a proactive approach to fault finding and troubleshooting, and identifying process improvements. Identifies compliance risks during the product development cycle. Coaches and mentors program/project teammates in the proper interpretation and application of quality system processes and procedure. Prepares and presents technical and PDP program/project details to managementListing originally posted at http