Overview

Role: Quality Engineer Medical Devices (Design Assurance & NPD)Location: IRVING, TXNumber of Positions: 3Role Description:Must Have Technical/Functional Skills Contact & non-contact metrology inspection OGP SmartScope advanced programming Keyence optical profilometer operation Blueprint reading with GD&T Optical comparators and digital microscopes White light scanning systems Hand gages, micrometers, and calipers Advanced mathematics (Trigonometry) MS Word and Excel proficiencyRoles & Responsibilities Perform dimensional inspections of medical devices and components using contact and non-contact metrologyequipment Collaborate with engineers to understand measurement requirements and recommend optimal inspection techniques Read and interpret blueprints including GD&T specifications for complex measurement requests Develop and execute advanced inspection programs on OGP SmartScope systems Collect dimensional data using optical comparators, digital microscopes, white light scanners, and hand gages Analyze and interpret measurement data to troubleshoot issues and guide customers toward practical solutions Handle biohazardous materials in accordance with safety procedures (as required) Perform additional metrology or lab support duties as assignedGeneric Managerial Skills, If any Strong analytical and problem-solving skills High attention to detail and measurement accuracy Clear technical communication skills Ability to learn new lab techniques quickly Ability to work independently and collaborativelyKey Words to search in Resume Metrology Technician Measurement Inspection Specialist OGP SmartScope Programming Keyence Profilometer GD&T Inspection Vision Inspection Systems Medical Device MetrologyRole Descriptions: "Under limited supervision and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines the duties and responsibilities for this position are:Provide quality engineering support for Cerenovus neurovascular products throughout product development design changes technical transfer (tech transfer) manufacturing transfer and sustaining activitiesPrepare develop review maintain and approve Quality Plans and Product Development Process deliverables including protocols reports specifications and engineering documentationReview and approve R&D/Engineering verification and validation protocols and reportsDevelop and maintain risk management records including DFMEA and PFMEA in collaboration with subject matter expertsSupport and provide quality guidance for process validation and equipment qualification activities including IQ OQ and PQProvide Quality Management System (QMS) support and maintain Quality documentation to ensure objective evidence is complete accurate and traceableLead or support audits Root Cause Investigations and closure of nonconformances deviations and CAPAs; support audit responses and verify effectiveness of implemented corrective and preventive actionsReview and approve Change Orders including CR/CN documentation and assess product process quality and regulatory impactApply statistical methods to process and product data including capability analysis sampling rationale and measurement system assessment as applicableSupport post-market quality activities complaint trending and design or process enhancementsWrite review revise and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) for Quality functionsInterpret new or upcoming quality and regulatory requirements and provide guidance to cross-functional teamsPartner with R&D Manufacturing Regulatory Operations Supplier Quality and other internal teams to create and approve deliverablesPerform other duties assigned as needed"Essential Skills: LCM Quality EnggDesirable Skills:Keyword:Skills: EIS : Medical Device & Regulations EIS : New Product Development (NPD) Methodology and ManagementExperience Required: 4-6