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Senior Quality Engineer, Product Development

Johnson & Johnson Cincinnati Full-Time
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Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer, Product Development located in Cincinnati, OH.

 

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit URL blocked - click to apply.

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In this role your primary responsibilities will include:  

 
  • Providing New Product Team Support for quality system design and audit
  • Launch and stabilize new product launches through steady-state manufacturing processes, change control, signal detection/escalation
  • Conducting audits to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards and providing compliance assessment and status.
  • Maintain awareness to changes in the industry and regulatory environments and apply this information to business practices at EES 
  • Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA (Food and Drug Administration) requirement
  • Prepare QA (Quality Assurance) system and assist in technical issues for manufacturing processes that are to be transferred to satellite facilities.
  • Manage established processes in support of steady state manufacturing (components and devices) in accordance with defined QA program for product transfers
  • Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for manufacturing, technical services and product development Audit and approve manufacturing, quality, engineering and validation / qualification documents for conformance to ETHICON ENDO SURGERY business practices and departmental procedures
  • Support development of product requirements, and design validation strategy
  • Act as liaison to Regulatory Affairs department to perform initial regulatory review of all engineering changes / modifications to products
  • Perform analysis of documents / information to ensure that all critical product characteristics have been identified and properly evaluated
  • Develop inspection and sampling plans, test methods, and transfer functions for components and products
  • Provide support and expertise in developing and executing a reliability strategy during new product development.
  • Apply advanced Quality Engineering/Scientific Method techniques/Six Sigma/Lean/ and Quality Tools to project tasks deliverables.
  • Plans and conducts projects and assignments with technical responsibility and strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders
  • Generally, operate more independently and may mentor or coach less experienced QEs.
  • Contributing to root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.
  • Ensure that process Quality control plans and Quality procedures are in accordance with product or process risk level and are consistently followed 



Qualifications
  • A minimum of a B.S. in Engineering or relevant Science/Technical field is required.
  • Advanced Degree in Engineering or Technical field is preferred.
  • A minimum of 4 years of work experience is required.  
  • Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.
  • Experience working with Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
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  • New product development experience is preferred.
  • Previous work experience engaging in a team-based environment is required.
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  • Experience in product/process safety risk assessment in a regulated industry is preferred.  
  • Experience conducting or contributing to the reliability assessments of product design is preferred.
  • Experience conducting and supporting the development of test methods in equipment, process, and product qualifications/validations is preferred.
  • Experience implementing and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics). Perform or guide Measurement Systems Analysis (MSA) is preferred.
  • Certified Quality Engineer from ASQ and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred.
  • Fundamental technical understanding of manufacturing equipment and processes is preferred.
  • URL blocked - click to apply
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Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United States-Ohio-Cincinnati-
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
Quality (Eng)
Requisition ID
8403190813
 

Recommended skills

Risk Analysis
Good Manufacturing Practices
Validations
Statistical Process Controls
Quality Management Systems
Product Quality Assurance
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Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
By caring for the world, one person at a time we aspire to help billions of people live longer, healthier, happier lives. This aspiration inspires and unites the approximately 129,000 employees of Johnson & Johnson across more than 275 operating companies in 60 countries. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. For more than 125 years, the Johnson & Johnson Family of Companies has been committed to caring for people around the world.

Our Family of Companies comprises:

  •  The world’s sixth largest consumer health company
  •  The world’s largest and most diverse medical devices
  •  The world’s sixth-largest biologics company
  •  And the world’s eighth-largest pharmaceuticals company

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