Job description
Role: Quality Engineer Medical Devices (Design Assurance & NPD)
Location: IRVING, TX
Number of Positions: 3
Role 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 proficiency
Roles & Responsibilities
Perform dimensional inspections of medical devices and components using contact and non-contact metrology
equipment
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 assigned
Generic 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 collaboratively
Key Words to search in Resume
Metrology Technician
Measurement Inspection Specialist
OGP SmartScope Programming
Keyence Profilometer
GD&T Inspection
Vision Inspection Systems
Medical Device Metrology
Role 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 Engg
Desirable Skills:
Keyword:
Skills: EIS : Medical Device & Regulations EIS : New Product Development (NPD) Methodology and Management
Experience Required: 4-6
Worksite address
Irving, TX, 75063, US
Who can apply
Review the original listing for location, eligibility and application requirements.