LCM Quality Engineer | Medical Devices

 

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

Skills: EIS : Medical Device & Regulations~EIS : New Product Development (NPD) Methodology and Management
Experience Required: 4-6