SENIOR NPI QUALITY OPERATOINS MANAGER

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.

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, 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 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 department's 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 Bachelor's degree, preferably in engineering: Mechanical, Electrical, Industrial or 
applicable science.
o Master's 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:

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