The Cardiovascular & Specialty Solutions (CSS) Group, part of
the Medical Devices sector within Johnson & Johnson, is recruiting for a Team Leader, Supplier Quality 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.
The Team Leader, supplier quality position
provides overall quality assurance leadership in the management of External and
Direct Manufacturing sites engaged in the production of Johnson and Johnson
products. The Team Leader will
supervise the Supplier Quality Engineers and will be responsible for all aspects
of Supplier Quality including, but not limited to:
- Conducting audits to good
manufacturing practices, international organization for standardization and any
other applicable standards.
- Providing complex product team
support for quality system design and audit, compliance assessment, and for
support of steady state manufacturing processes.
- Utilizing multifaceted industry
and process excellence standards on an expert level in daily quality operations,
including good manufacturing practices (GMP), equipment engineering system
(EES), and international organization for standardization (ISO).
- Addressing and correcting
product and process complaints.
- Reporting on contract manufacturer
performance metrics and management reviews.
- Overseeing audits of all quality
system categories to assess compliance to process excellence standards.
- Ensuring comprehensive measurement
systems to monitor effectiveness of quality and reliability systems to
identify, bracket, correct and prevent defects, and presenting reports to
- Handling complex technical issues
for manufacturing processes that are to be transferred to satellite
- Providing Quality Engineering
support to suppliers including inspection technique support,
verification/validation activities, CAPA and change management.
- Ensuring that FDA CFR Part 820 and
ISO 13485 regulations/standards are understood and followed at suppliers
- Providing leadership within the
group and help manage and direct the work of other Quality Engineers.
- Demonstrated ability to direct a
team in meeting departmental goals and objectives, to make effective oral and
written presentations, to prioritize and manage multiple projects consisting of
varying degrees of complexity and to analyze complex problems and apply
practical solutions is required.
- A minimum of a Bachelor's degree
is required, preferably in an Engineering, Life Science, or related discipline.
- A minimum of 5+ years of
experience is required.
- Supervisory experience is a plus.
- Experience in the Medical Device
industry is required
- Experience in the Pharmaceutical
industry is an asset.
- FDA and ISO regulations knowledge
is required, with FDA CFR Part 820 and ISO 13485 knowledge
- Auditing background is an
- Strong communication, teamwork,
and problem solving skills are required.
- Strong root cause analysis skills
- Experience or knowledge with
machining manufacturing processes and injection molding an asset.
- Six Sigma, Lean, or ASQ Certification
and training an asset.
- This position is located in Los
Gatos, CA and will require up to 20% travel.
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
United States-California-San JoseOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Quality (Eng)Requisition ID