Team Leader, Supplier Quality
Location:
San Jose , California
Posted:
April 02, 2017
Reference:
6911170119-en-us

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 management. 
  • Handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities. 
  • 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. 


Qualifications
Qualifications
  • 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 preferred.  
  • Auditing background is an asset. 
  • Strong communication, teamwork, and problem solving skills are required. 
  • Strong root cause analysis skills are required. 
  • 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.
 

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
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)
Requisition ID
6911170119

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.

Know someone who would be interested in this job? Share it with your network.