Job Description:

Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.Quality Engineer Expectations:Supports internal audit program as necessary.Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCsMaintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of correctionscorrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to managementMaintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAsPerforms trend analysis of CAPA, NCM, ComplaintCustomer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.Adheres to the company's Quality System (QS), writes and approves QS documentsAuthors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product municates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as neededConducts studies including Gauge R&R's to develop inspection methods and test equipment. Creates measurement system programs, when necessary.Establishes inspections and sampling procedures to ensure the control of quality at the most economical costsCreates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.Participates in customer and ISO audits.Quality Engineer Qualifications:Required:4-year degree in quality, engineering, or related fieldISO 13485 understanding & experienceDesired:2+ years in manufacturing environment in a technical support roleASQ Certified Quality EngineerFormal Six Sigma YellowGreen belt training