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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com (https://www.jnj.com.) .

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

Job Description:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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

types of defects, including the successful application of these techniques in the day-to-day in

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 process given to changes in the product/process.

Strategy

• Collaborates with the quality leaders to identify the required quality engineering skills and

competences that allow the execution of the strategic vision.

• Performs the strategic planning with the site leaders and with the product engineering team.

Works in team with other functions to establish the priorities of the business and assignment of

resources.

People

• Provides supervision, mentoring, coaching, performance revision, development plans and

planning of the succession for others (when applies).

o Responsible for communicating business related issues or opportunities to next management

level

o 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

o Responsible for ensuring personal and Company compliance with all Federal, State, local and

Company regulations, policies, and procedures

o Performs other duties assigned as needed

o Responsible for communicating business related issues or opportunities to next management

level

o Responsible for following all Company guidelines related to Health, Safety and Environmental

practices as applicable.

o 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

o Responsible for ensuring personal and Company compliance with all Federal, State, local and

Company regulations, policies, and procedures

o Performs other duties assigned as needed

Qualifications / Requirements:

As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable

science.

• Master or Doctorate in applicable sciences, preferable.

• 8 to 10 years of work experience, or demonstrated performance.

• Use of computer packages.

• Ability to effectively deal and negotiate with representatives of various governmental agencies

and auditing agencies.

• Excellent communication skills in English, spoken and written.

• Ability to perform “active involvement” in the solution of problems and resolution of problems,

preferably.

• Capacity to solve problems providing good judgment is highly desired.

• Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus.

Required Skills:

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management