Johnson & Johnson Careers

MANAGER CUSTOMER QUALITY FAILURE ANALYSIS 

Juarez, Mexico
Quality Assurance


Job Description

Requisition ID: 1905764635W

“Johnson & Johnson companies are equal opportunity employers”

 

The Global Job Posting policy promotes the commitment to the advancement and development of our employees.  We invite you to read this posting and apply if you are interested in the position and meet the requirements.

 

Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. We help patients around the world regain their health, their energy and their lives. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster, Inc. has pioneered innovative technological advancements for more than 30 years. Join us as we continue to look for new and better ways to help physicians heal more hearts. Because that is what we do -- we put lives back in rhythm. 

 

Searching the best talent for: Manager MD Customer Quality Process Owner

JOB SUMMARY*

As the MD Complaint Process Manager, you will be part of a team that has End-to-End Complaint Process oversight and will continue spearheading process alignment for Medical Device Customer Quality, while identifying and delivering continuous improvements for the Enterprise Complaint Management (ECM) process and system.

SECTION 2: DUTIES & RESPONSIBILITIES*

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

As the MD Complaint Process Manager, you will have responsibility for, but not limited to:

  • Align the requirements, definition and sustainability of execution of the complaint process from intake through regulatory reporting, inclusive of data and technology.
  • Oversee the governance of ECM Super User Network
  • Participate in future state process definition and alignment and support of any necessary changes needed to enable business performance and ensure sustainability of deliverables.
  • Drive key Strategic initiatives in support of MD harmonization and improvement (e.g. Global Intake Strategy, Digital Surgery Platform Deployment, Electronic Complaint Submission Tool expansion, Business Adoption Platform, External Manufacturer process)
  • Support Customer Quality functional pillars for management of ECM related CAPA, NC and Audit outcomes as well as Platform Audit and CAPA actions.
  • Provide system and process expertise and mentorship in Acquisition & Divestitures for Complaints Process
  • Collaborate and interact with Supply Chain Shared Services, MD CQ Analytics Business Quality, Deliver, Regulatory Affairs, Sales, Service & Repair, Information Technology and Quality Systems.
  • To be part of a team providing shared services to the business for specification changes & training, IT Platform Management, deployment of additional processes, cross quality system harmonization.
  • Sustain the efficiencies obtained via prior improvements and enhancements and continue to identify and drive additional opportunities in this area
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


Qualifications

SECTION 3: EXPERIENCE AND EDUCATION*

  • BA/BS/BSN in Scientific, Technical, Engineering, or Nursing field required
  • Minimum of 6 years working in Medical Devices/Diagnostics and/or other regulated healthcare industry experience required
  • Multi-site and Matrixed organization experience

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

  • Demonstrated Global Mindset
  • Demonstrated leadership skills working in environments with fluctuating and competing priorities is required.
  • Experience US/ OUS regulated environment is required
  • Strong communication and presentation skills
  • Project management experience with prioritizing multiple simultaneous projects is required.
  • Process excellence techniques knowledge (ie. industrial engineering, six sigma, black belt, lean, or similar) are required.
  • Knowledge of Medical Device Quality System Processes and Compliance is preferred.
  • Working knowledge of global complaint handling processes is preferred.

 



Primary Location
Mexico-Chihuahua-Juarez-Circuito Interior Norte 1820 Parque Industrial
Organization
Cordis de Mexico S.A. de C.V. (8286)
Job Function
Quality Assurance
Requisition ID
1905764635W