Quality Operations Manager

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.We are searching for the best talent for Quality Operations Manager to be in Juarez, SalvarcarPurpose: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: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.- 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 exe