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.
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.
- 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
- 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.
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,
- The ability to think on the feet and providing sound judgment
- A thorough understanding of GMP/ISO regulations and validation
- 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.
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
- 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
- The ability to perform "hands on" troubleshooting and problem
- 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
Depuy Orthopaedics. Inc. (6029)Job Function