NPI Quality Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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Job Description:

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

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.

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Preferred Skills: