Staff Quality Engineer

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 STAFF QUALITY ENGINEER to be in Tijuana.****Purpose**:The Site Senior Quality Source Engineer serves as the on-site Johnson & Johnson Medical Devices (JJMD) quality engineering representative for the Strategic Collaborator (SC). In collaboration with the SC, he/she utilizes quality engineering principles and problem-solving skills to improve and maintain JJMD products and processes. He/she supports the SC quality engineering team on initiatives impacting JJMD products and processes, including validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Senior Quality Source Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J Policies, and applicable regulations and standards.**You will be responsible for**:Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:- Reviews and approves key quality records as they related to JJMD products such as;- Site Validation Master Plan- Validation protocols and reports per Change Control Processes- High-risk CAPAs (i.e., Field Action, External Observations)- New or revised inspection plans and associated sampling strategies- Where necessary, collaborate with PSC in failure investigation and corrective action planning for High-Risk CAPAs (i.e. Field Action, External Observations) involving JJMD products.- Coordinates JJMD review and approval of;- Non-routine rework in collaboration with other required JJMD functions such as Design Quality, Product Management, and Sustaining Engineering.- Use-as-Is Nonconformance Disposition in collaboration with other required JJMD functions such as Regulatory Affairs and Medical Affairs.- Supports Technical Assessments in collaboration with SC site compliance, JJMD Supplier Quality Compliance, and JJMD Product Management.- Partners with SC Quality Engineering, JJMD Medical Affairs, and JJMD R&D/PM in the development of Process Failure Mode Effects Analyses (pFMEAs) and corresponding Control Plans.- Supports improvement plans to address below-target metrics and negative trends.- Serves as the Site Liaison’s deputy.- Partners with SC on Recall Prevention and External Audit Readiness initiatives.- Responsible for communicating business related issues or opportunities to next management level.- 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.- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.- Performs other duties assigned as needed.**Qualifications** Qualifications and requirements**:- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.- 4-6 years related experience preferred.- Experience working in both an FDA and European regulatory environment is preferred.- This position will require relevant experience working in manufacturing/operations.- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.- Experience with a proven track record of implementing appropriate risk mitigation.- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present