Senior Npi Quality Operatoins 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.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for SENIOR NPI QUALITY MANAGER for Horizontes Site Ciudad Juarez.

Purpose:

Plans coordinates and directs quality assurance programs designed to ensure the continuous production of products consistent with established standards through the following responsibilities either personally or through subordinates.
At this level the position has a major impact on business results and typically management responsibility for the group of professionals under his/her charge.
If CSS position: This position will have responsibilities across the ETHICON and Cardiovascular and Specialty Solutions (CSS) Family of Companies of Johnson and Johnson)companies including a range of multiple product platforms such as General Surgical Devices Sutures ENT Infection Prevention Electrophysiology and Surgical and Non-Surgical Aesthetics.

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 supports quality improvement initiatives such as process and product characterizations
leading to continuous improvement / cost.
Reviews / analyzes the effectiveness of PDCA Six Sigma Kaizen Lean Techniques and other
improvement tools and programs.
Conducts benchmarking to develop more effective methods to improve quality.
Establishes and formulates quality metrics to maintain quality assurance objectives and alignment with plant objectives.
Supports the development of quality engineering and quality compliance with appropriate skills
for new product introduction and product life cycle management.
Promotes and supports the implementation of quality product and process improvement projects.
Reviews and approves engineering change orders (ECOs).

Evaluates monitors and analyzes quality costs to maintain a quality system in accordance with
medical industry standards.

Compliance / Regulatory
Reviews / analyzes whether current products and processes (including actions or decisions
taken) comply with standards such as QSRs ISO 13485 etc.
Leads preparation activities for regulatory agency audits including active participation as SME
or Escort (e.g. FDA JJRC BSI etc).
Reviews and approves responses to internal or external audit observations to ensure compliance with internal procedures and applicable regulations.
Establishes and properly maintains required documentation of quality assurance activities
and/or quality systems.
Ensures periodic line audits are conducted to evaluate GMPs production controls batch
segregation and process audits in accordance with JJPS. Reviews results of area audits to
ensure corrective and preventive actions are appropriate.

Finance
Defines monitors and manages the departments central budget/cost.
New Product / Process Introduction
Collaborates with NPI and the operations and engineering departments to develop conduct and
approve product and process validation strategies.

Product Quality Control & Disposal and Performance Standards
Leads and attends NC Review meetings as a member of MRB.
Reviews and approves investigations bounding documentation review and approval of nonconformances (NCs) corrective and preventive actions (CAPAs) customer complaints and
Escalation of quality issues as applicable.
Responsible and owner of material identification material segregation classification of defect
types including the successful application of these techniques in day to day manufacturing.
Gives direction and allocates resources for the resolution of complex (technically) problems
associated with the manufacturing process at a local or franchise level.

Product / Process Qualification
Reviews and approves process validation strategies.
Ensures that periodic maintenance and review of CTQs is performed on the manufacturing
process to ensure continued customer satisfaction.
Approves the review and maintenance of PFMEAs Quality Control Plans Process Instructions
and additional manufacturing documents.
Supports in the development and proper implementation of process monitoring and control
methods consistent with the risk level of the process/product.
Promotes the use of innovative tools for timely risk detection and mitigation. Determines the
effectiveness of these techniques on previously implemented improvements.
Responsible for and owns the risk assessment process including the conduct documentation
review or maintenance of current risk and hazard analysis documentation such as process
FMEA given product/process changes.

Strategy
Collaborates with other quality leaders to identify required quality engineering skills and
competencies to enable execution of the strategic vision.
Conducts strategic planning with site leaders and product engineering team. Team with other
functions to establish business priorities and resource allocation.

People
Provides supervision mentoring coaching performance review development plans and
succession planning for others (where applicable).
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:

o Minimum Bachelors degree preferably in engineering: Mechanical Electrical Industrial or
applicable science.
o Masters or Ph.D. in applicable science is preferred.
o 8-10 years of work experience or demonstrated performance.
o Computer package management.
o Ability to deal effectively and negotiate with representatives of various government agencies
and auditing agencies
o Excellent communication skills in English both written and oral.
o Ability to perform hands on problem solving and problem solving is preferred. Ability to
problem solve and provide sound judgment is highly desired.
o Certification such as CQA CQE CQM (preferred) CBA MBB or BB a plus

Required Skills:

Preferred Skills: