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 https: //www.jnj.com

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About Cardiovascular

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

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for QUALITY OPERATIONS MANAGER

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:

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

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.

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 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.