Quality Assurance Engineer
US - MA - Chelmsford
The Quality Engineer leads investigation of product and process problems and develops dispositions, modifications, and corrective actions for recurring or non-recurring discrepancies. As a leader and key cross-functional facilitator interfacing with manufacturing, engineering, customer, vendor and contract manufacturers to ensure requirements are met, the Quality Engineer is skilled at developing and implementing quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. The Quality Engineer ensures product quality conforms to established company, customer and regulatory requirements, reviews, analyzes and reports on quality discrepancies related to assemblies and processes and planning and implementing process quality plans for new product introductions.
· Leads the development, modification, and maintenance of quality evaluation and control plans and protocols for processing materials into partially finished or finished products.
· Manages assigned failure analysis and report generation as determined by the Quality Leader.
· Leads quality meetings with factory work cells.
· Supports factory process certification activities for new product introductions (NPI process).
· Leads problem solving teams utilizing 8D methodology.
· Manages quality data for accuracy and report generation.
· Leads Corrective and Preventive Action (CAPA) activities to drive performance improvements.
· Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.
· Audits quality systems for deficiency identification and correction.
· Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001), Advance Problem-Solving methods, and that documentation is complete and compliant with requirements.
· May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
· Conducts Data Analysis using the Quality Engineering body of knowledge, with an emphasis on lean and Six-Sigma methods, Quality Control, sampling, inspection and measurements.
· Support all company safety and quality programs and initiatives.
Skills Required / Qualifications
· B.S. in a technical discipline or equivalent working experience in a Quality Management environment is required.
· Knowledge of quality related management standards (ISO 9001) and product regulations affecting semiconductor manufacturing related to capital equipment products including the Copy Exactly (CE!) methodology.
· Must be able to demonstrate the application and appropriate use of statistical methods and tools such as Gauge R&R, Statistical Process Control, Capability analyses etc.
· Certified Quality Engineer (CQE) is a plus. Knowledge of quality concepts such as Lean, 5s, MUDA (Waster Elimination), Six Sigma, ISO 9001, and ISO 14001 are desired.
· Ability to perform supplier audits (SSQA) may be required for local NPI suppliers. Supplier Quality Engineering (SQE) background a plus.