SENIOR QUALITY OPERATIONS LEAD (PRIMER TURNO)

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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.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
An internal pre-identified candidate for consideration has been identified.
However, all applications will be considered.
We are searching for the best talent for Senior Quality Operations Lead to be in Juarez, Horizontes 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.
You will be responsible for.
Under general direction and in accordance with all federal, state, and local laws/regulations and Johnson & Johnson Corporate procedures and guidelines, this position will 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 , etc.
Leads preparation activities for regulatory agency audits, including active participation as "SME" or "Escort" (e.
.
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 non conformances (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).
Responsible for communicating business related issues or opportunities to the next level of management.
For those who supervise or manage personnel, responsible for ensuring that subordinates follow all Company guidelines related to HSE practices and that all resources necessary to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties as assigned as required.
Qualifications Minimum bachelor’s degree, preferably in engineering.
Mechanical, Electrical, Industrial, or applicable science.
Master's or Ph.
.
in applicable science is preferred.
8-10 years of work experience or demonstrated performance.
Computer package management.
Ability to deal effectively and negotiate with representatives of various government agencies and auditing agencies.
Excellent communication skills in English both written and oral.
Ability to perform "hands on" problem solving and problem solving is preferred.
Ability to problem solve and provide sound judgment is highly desired.
Certification such as CQA, CQE, CQM (preferred), CBA, MBB or BB a plus.