JOB BRIEFING Our Quality Engineers are a key part of a multidisciplinary product development and continuation engineering team. Specifically, Operations Quality is key to establishing and sustaining our business culture of continuous improvement by leveraging data to improve processes, eliminate waste, and compel the business and our customers to take action. This position is responsible for tactical management of the quality relationship between Nextern and key customers. The role advocates for the customers' quality expectations and requirements of our day to day performance in engineering, manufacturing, and supply chain, while balancing accountability between both companies to achieve exception product quality performance in compliance with government and regulatory agency requirements and directives. DUTIES AND RESPONSIBILITIES: Achievement of KPI Targets: This role must be proficient at achieving outcomes on-time, with high quality documentation content, and cross-functional team awareness/support (internal & external: CAPA & SCAR Processes: Process Qualification & Validation; Equipment; Selection & Qualification; Process Control & Yield/Trend Monitoring; Return Material Authorization; Failure Analysis of Returned Products; Servicing & Refurbishment of Fielded Products; Non-Conforming Material Processing. Technical Expertise: Printed Circuit Board Assemblies: Pneumatic Pumps & Valves; Cables & wired interconnect assemblies; Molded Plastic Parts (including pad/laser print suppliers); Gluing, Mating, and Fastening Processes for Enclosures, Displays, Power Supplies; Mechanical fastener & chassis components; Electromechanical connectors & fasteners; Extruded Plastics; Cable Winding/Coiling; Plastic Tip and Guide Body Forming; among others. Business Systems & Software Tools: This role must be competent, trainable, and adaptable to the daily use of such systems, applications, and tools, among others: Database Analysis (Excel, Pivot Chart/Tables, Access, VBA Scripts, etc…); Material/Inventory Movements (ERP Systems, Receiving Inspection Processing, Non-Conforming Material Processing, RMA Processing, Epicor, etc…); Enterprise QMS (Master Control, Grand Avenue, etc…); Common Business Applications (Microsoft Office), etc.. Leadership & Overall Contribution: Continuous Improvement; Committed to learning, education, and training/certification in the disciplines of Six Sigma and Lean; Data Analysis: must be technically savvy in connecting data to a story; must show exceptional aptitude toward being able to summarize and present data in a professional manner; and Customer Service & Management. Requirements Bachelor's Degree (BS), with 3+ years of professional experience but with relevant work experience (intern, laborer, etc…) wit hin a highly regulated industry, such as medical device, pharmaceutical, aerospace, automotive, etc. English proficiency preferable Computer skills required: reference Business Systems & Software Tools above Preferably with Intermediate English proficiency Benefits Competitive compensation package
