As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**Job Function**:
Quality
**Job Sub Function**:
Quality Assurance
**Job Category**:
People Leader
**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, Mexico, Ciudad Juarez, Mexico
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
**We are searching for the best talent for NPI QUALITY MANAGER for Salvarcar, Ciudad Juarez.**
**Purpose**:
Plans, coordinates, and directs the quality assurance programs designed to ensure the continuous production consistent with the established standards through the following responsibilities, either personally or through his/her subordinates.
**You will be responsible for**:
In accordance with all applicable federal, state and local laws/regulations and Corporate
Johnson & Johnson, procedures and guidelines, this position:
**New Products / Process Introduction**
- **Collaborates with NPI and with the operations and engineering departments to develop, conduct**
**and approve validation strategies of products and processes.**
**Business Improvement**
- Leads or support quality improvement initiatives, such as the characterization of processes and
products that leads to continuous improvements / cost.
- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other
tools and improvement programs.
- Performs benchmarking in order to develop more effective methods to improve quality.




- Establishes and formulates the quality metrics to maintain the quality assurance objectives and
alignment with the objectives of the plant.
- Supports the development of quality engineering and the compliance with the quality with the
adequate abilities for the introduction of new products and product life cycle management.
- Promotes and supports the implementation of quality, product and process improvement projects.
- Revises and approves Engineering Change Orders (ECOs).
- Evaluation, monitoring and analysis of the quality costs in order to maintain a quality system
according to the medical industry standards.
**Compliance / Regulatory**
- Revises / analyzes if the current products and processes (including performed actions or
decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.
- Leads the preparations activities for regulatory agencies audits, including the active participation
as “SME” or “Escort” (for example: FDA, JJRC, BSI, etc.).
- Revises and approves the answers to internal and external audit observations ton ensure the
compliance with the internal procedures and applicable regulations.
- Establishes and properly maintains the required documentation of quality assurance activities
and/or quality systems.
- Ensures the performance of periodical audits of the line to evaluate GMPs, production controls,
lot segregation and process audit according to JJPS. Checks the results of the audits of the area




to ensure that the corrective and preventive actions are adequate.
**Finances**
- Defines, monitors and administers the central budget of the department/cost
**Product Quality, Control and Disposition and Performance Standards**
- Directs and attends to Revision meetings of NCs as a member of MRB.
- Revises and approves the investigations, bounding, documentation, revision and approval of the
non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and
escalation of quality problems when applies.
- Responsible and owner of the identification of material, material segregation, classification of the
manufacturing.
- Provides direction and assigns resources for the resolution of complex problems (technically)
associated to the manufacturing process at a local or franchise level.
Product Grading / Process
- Revises and approves process validation strategies.
- Ensures the realization of periodical maintenance and revision of the CTQs in the manufacturing
process to guarantee the continuous satisfaction of the customer.
- Approves the revision and maintenance of PFMEAs, Quality control Plans, Process Instructions
and additional manufacturing documents.
- Provides support to the development and proper implementation of process monitoring and
control methods consistent with the process/product risk level.
- Promotes the use of innovative tools for the timely detection and mitigation of risks. Determines
the effectiveness of these techniques in the improvements previously implemented.
- Responsible and owner of the risk assessment evaluation including the realization,
documentation, revision, maintenance of current risk and documentation of the risk assessment
such as FMEA of the

📌 Npi Quality Manager (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez