||Quality Engineer II - Equipment
Take a key role in developing and improving NxStage’s sterile, single use disposables products. The Quality Engineer is involved in all parts of a product’s life, from feasibility evaluation for new features and products to improving the quality, performance,
and cost of dialysis therapy. The incumbent will be part of a team with responsibility for supporting a specific product line. Close collaboration with manufacturing, quality, regulatory, and product management counterparts is key to quickly responding to
issues, completing projects, and launching new products.
• Support Engineering in the development, testing, verification, validation and commercialization of modification of products to meet patient’s needs.
• Review design verification and design validations based on existing or modified specifications and standards.
• Provide support for product engineering, design development, integration, test and evaluation
• Apply state of the art methods to the creation and modification of NxStage products.
• Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
Lead / participate in Risk Management activities to ensure process shortcomings are identified and appropriately addressed
• Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
• Manage routine small projects without assistance
• Use problem solving and corrective action projects using techniques such as DMAIC or 8-D and appropriate statistical tools to resolve design problems and address quality improvement opportunities.
• Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
Facilitate collaboration between multiple manufacturing sites and business units.
• Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
• Support reliability improvements to existing & new products.
• Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.
• Recommend design and continuous improvement projects
• Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
• Complete activities associated with the formal release of product to finished goods
• Process non-conforming material reports including MRB dispositioning.
• Develop and implement instructions/methods for inspecting, testing and evaluating product conformance to specification.
• Travel (domestic and international) up to 10% is required.
• B.S. or equivalent experience in Mechanical, Materials, Industrial, or Plastics Engineering
• 2+ years experience in medical product design and/or sustaining engineering.
• Working understanding of molding and extrusion processes preferred
• Strong statistical background preferred
• Excellent written and oral communication
• Prior complaint processing experience
• Bilingual in English and Spanish preferred
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