Sr. Quality Operations Manager

**Description**At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.We are in this for life.We are changing the trajectory of human health, YOU CAN TOO.**We are searching for the best talent for **Sr. Quality Operations Manager **to be in Juarez.**Porpose:This position will have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span 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**:Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:- Business Improvement- Leads or supports quality improvement initiatives, such as characterization of process and products that lead to continuous improvement / 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 the quality.- Establishes and formulates the quality metrics to maintain the goals of quality assurance and alignment with the objectives of the plant.- Supports the development of quality engineering and the compliance with the adequate skills for the introduction of new products, and management of the life cycle of the product.- Promotes and supports the implementation of quality, product and process quality improvement.- Revises and approves engineering change orders (ECOs).- Evaluation, monitoring and analysis of the quality costs to maintain a quality system according to the medical industry standards.Compliance / Regulatory:- Revises / analyzes if the current products and processes (including actions or decisions performed) comply with the regulations, such as the QSRs, ISO 13485, etc.- Leads preparation activities for audits by regulatory agencies, including the active participation as “SME” or “Escort” (e.g. FDA, JJRC, BSI, etc.).- Revises and approves answers to internal or external audit observations to ensure the compliance with the internal processes and applicable regulations.- Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.- Ensures the performance of the periodical audits of the line to be evaluated, GMPs, production controls, lot segregation, and process audits according to JJPS. Revises 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 Revision meetings of NCs as member of the MRB.- Defines, monitors and administers the central budget of the department/cost.- Collaborates with NPI and with the operations and engineering departments to develop, conduct and approve validation strategies of products and processes.- Directs Revision meetings of NCs as member of the MRB.- Revises and approves the investigations, bounding, documentation, revision and approval of the nonconformities (NCs), preventive and corrective actions (CAPAs), customer complaints and Escalation of quality problems when applicable.**Qualifications**:- 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- Ability to effectively deal and negotiate with representatives of various g