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
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.
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
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
- 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
- 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
minimum of a Bachelor’s Degree is required, preferably in Engineering or
related technical field is required.
minimum of 6 years of manufacturing (industrial, quality, process excellence, etc.)
experience is required.
of lean principles is strongly preferred.
or knowledge with machining manufacturing processes and injection molding is
understanding of new product
introduction processes, and expertise in process qualifications/validations
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.
ability to perform "hands on" troubleshooting and problem solving is
ability to think on the feet and providing sound judgment is highly desired.
technical understanding of manufacturing equipment and processes is required.
thorough understanding of GMP/ISO regulations and validation regulations is
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 Companies are equal opportunity employers.
United States-California-San JoseOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Quality (Eng)Requisition ID
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.