Senior Quality Operations Lead

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 Job Function: Quality Job Sub Function: Quality Job Category: People Leader All Job Posting Locations: Ciudad Juarez, Chihuahua, 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. Our 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 QUALITY OPERATIONS MANAGER for Salvarcar, Ciudad Juarez. Purpose: Under the direction of the Site Quality Lead and with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Quality Assurance support to the Supply Chain including Project support, and directly supervises QA Engineers and non-exempts in day to day activities supporting manufacturing lines, operator certification program, incoming and finished good inspections, and CME environmental monitoring, all in accordance with applicable regulations and Ethicon written specifications and quality standards. 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: ESSENTIAL FUNCTIONS 1. Administers the deployment and utilization of resources for tactical day to day work. This includes working with Operations, Materials Management and QA to facilitate testing and release scheduling. 2. Administers the testing and controlling of raw material, finished product quality and in process quality, assuring compliance with company standards and applicable government regulations. 3. Responsible for the evaluation and disposition of WIP and questionable raw materials. 4. Advises Business Units on inspection and testing procedures. Makes recommendations where necessary. 5. Initiates and maintains interplant communications of quality issues. 6. Maintains close interaction and network with peers at Global Plants to address quality related issues. 7. Administers available resources to achieve a reliable, efficient and productive operation. 8. Facilitates QA support to new product launches to assure a successful implementation. 9. Fosters teamwork and supports total associate involvement. 10. Assists Site Quality Lead in the preparation of the Annual Departmental Budget. 11. Resides as back up of Site Quality Lead for signature authority and meeting representation. 12. Approves purchases and expense reports submitted by direct reports. 13. Analyzes plant reports for significant quality trends and report’s conclusions. 14. Supports Internal Regulatory Compliance Function as required. 15. Monitors Good Housekeeping practices, employee hygiene, and employee safety. 16. Participates in the development of procedures, specifications, cost control planning, self-inspection methods, and systems of QA. Enforces implements and follows up on all procedures and specifications. 17. Approves specification and process changes per applicable procedures. 18. Participates with Operations in developing, coordinating and implementing projects for improvement of processes and/or products. 19. Provide feedback to operations on problems related to quality and/or compliance. 20. Supports/initiates investigations of non-conformances. 21. Supports Operations in evaluation and implementation of action plans to eliminate root causes of non-conformances. 22. Support and approve validations as required. 23. Provides support to plant wide initiatives such as ergonomics, safety, environmental, etc. 24. Actively supports other plant functions in the implementation of company programs and projects. 25. Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company. • Participate and support safety initiatives within the facility, such as emergency response, ergonomics, safe behavior program, etc. • Be aware of, and comply with, Company policies on Safety. • Report accidents, incidents, near misses, and hazardous situations in a timely manner and participate in the corrective action process. • Ensure proper use and maintenance of all personal protective equipment required to safely perform the job. • Ensure all personnel under their facilitation comply with all safety policies and procedures (Plant-wide and applicable to work area). • Participate in the deployment of Safety policies. • Ensure department safety programs are implemented and maintained to meet corporate goals. 26. Provides support to Internal Audit Program with Internal Auditor to meet schedule achievement. As applicable, owns Internal audit observations to address and solve potential quality issues. 27. Host active communication with G9 countries as Ethicon representative for Wound Closure division to provide timely response to China customer complaint demands. 28. Lead the several sections of the Quality assurance organization, whose primary function is to provide timely information to Management and Manufacturing on the status of nonconformance to requirements. 29. Have the necessary independence, authority and responsibility to initiate action to prevent nonconformities, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product. 30. Scope of operation encompasses approximately 30 – 80 employees on multi shift schedules. 31. Review and participate in personnel development programs. 32. Provides active support to investigation and resolution of Product Issue Escalations. OTHER RESPONSIBILITIES Assist Site Quality Head in the preparation of the Performance/Potential Appraisals for the Quality Operations related functions. Directly supervises Quality Engineers, and non-exempt associates, Participates in the interview and selection of qualified employees for authorized job openings. Trains, coaches and develops subordinates and Quality Operations function associates as valuable resources in the development of World Class Manufacturing initiatives. Ensures that the disciplinary actions are executed in a fair and consistent manner, according to Company rules and policies. Recommends salary increases and promotions for direct subordinates and Quality Operations function associates. 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: • This position will require relevant experience working in manufacturing/operations. • A minimum of a bachelor’s Degree, preferably in Engineering or related technical field. Education Bachelor’s Engineering Degree preferably or related technical field. Master Engineering Degree preferably or related technical field. Experience More than 10 years related experience. Required 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 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 #J-18808-Ljbffr