Staff Quality Engineer
San Jose , California
April 02, 2017

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Quality Engineer  aligned to Pulsar Vascular located in Los Gatos, CA.


The CSS Group consists of six diverse businesses including Accelerant, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.


Codman Neuro is a global neurosurgery and neurovascular company that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery, as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Pulsar Vascular is newly acquired under Codman Neuro and is a leading developer of breakthrough platform technology for the neurovascular treatment of complex aneurysms, including the PulseRider system, a minimally-invasive, self-expanding nitinol implant. 


Job Summary

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) 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.


Job Qualification:

  • A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field is required.
  • A minimum of 6 years of manufacturing (industrial, quality, process excellence, etc.) experience is required. 
  • Knowledge of lean principles is strongly preferred.
  • Experience or knowledge with machining manufacturing processes and injection molding is preferred.
  • An understanding of new product introduction processes, and expertise in process qualifications/validations required.
  • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. A proven track record of implementing appropriate risk mitigation is an asset. Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
  • Experience working in a regulated environment is required.
  • Knowledge of, and experience with, applicable standards, GxP requirements and regulations is required.
  • Experience managing projects and demonstrating project leadership abilities is required.
  • The ability to perform "hands on" troubleshooting and problem solving is required. 
  • The ability to think on the feet and providing sound judgment is highly desired.
  • Good technical understanding of manufacturing equipment and processes is required.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred. 
  • This position will be based Los Gatos, CA and may require up to 10% travel, including possible international travel.

Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.


Johnson & Johnson Companies are equal opportunity employers.


Primary Location
United States-California-San Jose
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)
Requisition ID

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