Quality Operations Manager
hace 3 días
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 Quality Operations Manager to be in Juarez.**
The Site Quality serves as the on-site Johnson & Johnson Medical Devices (JJMD) representative for the External Strategic Collaborator (ESC). He/she ensures that appropriate communication channels are established and maintained between JJMD and ESC. The Sr. Manager, Quality Operations oversees site activities with potential impact to JJMD product quality, quality management system, and brand integrity. The Sr. Manager, Quality Operations is accountable for ensuring that the ESC has a clear understanding and ability to execute to the JJMD Quality System and the Quality Agreement requirements. Critically, the Sr. Manager, Quality Operations partners with the respective ESC site management team for their sphere of influence to develop and support initiatives and responses to internal quality issues. He/she partners with ESC assessing their Quality System through input to Management Review and Joint Quality Reviews at the ESC and JJMD levels. Further, the Sr. Manager, Quality Operations has the necessary independence, authority and responsibility to communicate quality problems according to the J&J escalation standard and Quality Agreement. The Sr. Manager, Quality Operations is a key member of the JJMD Supply Chain team as well a key partner to the ESC Supply Chain network
**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:
- Oversee execution of the Quality Agreements and Transitional Service Agreements (TSA) between ESC and JJMD.
- Oversee Lot Release Certification and Monitoring Program for JJMD products:
- Establish and maintain training development of lot release activities
- Establish and maintain training development and execution of JJMD quality personnel performing lot release certification and monitoring activities
- Track and analyze lot release certification and monitoring data in order to measure program effectiveness and to identify trends. Report data analysis, including any negative trend, through Management Review and Joint Quality Review.
- Review and approve Nonconformances and CAPAs resulting from the lot release certification and monitoring processes, including root cause investigation, product impact assessment, bounding, and applicable corrective action plans.
- Oversees Site JJMD Quality Engineering activities as defined by the Quality Agreement.
- Supervise site JJMD quality organization, including salary and wage associates:
Evaluate and recommend staffing requirements to ensure maximum utilization of personnel to fulfill department objectives Set departmental yearly goals
- Recommend salary increases and promotions for direct reports
- Recruitment and onboarding of new staff
- Conduct performance appraisal, compensation, people development plans, and training curricula
- Approve departmental purchases and personnel company expenses
- Perform team communications
- Promote, terminate, and transfer direct staff, as required
- Collaborate with ESC on escalation decisions as per Quality Agreement
- External audit support for JJMD products and/or quality systems
- Reviews site monthly dashboard and establishes (with ESC) improvement plans to address below target metrics and negative trends.
- Participate of the site Quality System Management Review (QSMR)
- Support Joint Quality Review process 4.10. Support ESC/JJMD Product Focus Teams.
- Provides input into the site Quality Plan & yearly Quality Objectives
- Provide ESC with guidance and connection to JJMD organization towards the resolution of issues and/or improvements related to JJMD Products.
**Qualifications**:
**Qualifications and requirements**:
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