Staff Quality Engineer
Location:
Miramar , Florida
Posted:
March 17, 2017
Reference:
4223170308-en-us

Codman Neuro Companies of Johnson & Johnson is seeking a Staff Quality Engineer located in Miramar, Florida.

 

Codman Neuro Companies of Johnson & Johnson is one of the largest, most innovative and comprehensive neurological business in the world. Codman Neuro offers an unparalleled breadth and depth of products, services and programs in the areas of neurovascular and neurological treatments. Building on its legacy and strengths, Codman Neuro is more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than the company could accomplish on its own.

 

Staff Quality Engineer:

Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plans and conducts projects with moderate to high technical responsibility, complexity, or strategic input. Receives summary instructions from technical Quality leaders at various levels, in addition to other functional stakeholders.

 

Key Technical Responsibilities:

  • Demonstrates strong proficiency in applying established tools and methods (for example, Six Sigma, Lean, Kaizen, etc.) to identify and realize new product or process introductions, as well as process and business improvements.
  • Leads, and/or contributes to, the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
  • Leads, contributes to the reliability assessments of product design.
  • Leads, and/or contributes to, root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions.
  • Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.
  • Develops, implements, and/or maintains process Quality control plans that are in accordance with product risk level, and ensures those plans are consistently followed.
  • Develops, implements, and/or maintains production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics).
  • Mentors others in various technical capabilities.
  • Interprets standard and non-standard sampling plans.
  • Participates in technical reviews as appropriate
  • Supports execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies.


Qualifications

Preferred:

  • Knowledge of lean principles
  • A proven track record of implementing appropriate risk mitigation is an asset. Technical training and experience using Statistics, Lean and Six Sigma Methodologies including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
  • The ability to think on the feet and providing sound judgment
  • A thorough understanding of GMP/ISO regulations and validation regulations
 
Required:
  • A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field.
  • A minimum of 6 years of manufacturing (industrial, quality, process excellence, etc) experience. 
  • Experience or knowledge with medical device manufacturing processes, including extrusion, injection molding, braiding, and hydrophilic coating.
  • An understanding of new product introduction processes, and expertise in process qualifications/validations
  • In-depth knowledge of product/process Risk Management (FDA and ISO standards)
  • Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations.
  • Experience managing projects and demonstrating project leadership abilities.
  • The ability to perform "hands on" troubleshooting and problem solving. 
  • Good technical understanding of manufacturing equipment and processes

This position will be based in Miramar, FL and require up to 20% travel, including possible international travel.


Primary Location
United States-Florida-Miramar
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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