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Quality Operations Manager
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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 Ciudad Juarez.**
The Site Quality serves as the on-site Johnson & Johnson Medical Devices (JJMD) representative for theExternal Strategic Collaborator (ESC). He/she ensures that appropriate communication channels are established and maintained between JJMD and ESC. The Sr. Manager, Quality Operations overseas 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, theSr. Manager, Quality Operations partners with the respective ESC site managementteam 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, authorityand 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.
Under limited supervision 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.
- 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.
- 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 andCompany compliance with all Federal, State, local and
- Company regulations, policies, and procedures.
- Performs other duties assigned as needed
**QUALIFICATIONS**:
- Stakeholder management.
- Leadership and management skills.
- Excellent communication and interpersonal relation skills.
- Regulatory compliance knowledge and skills.
- Advanced Quality Systems knowledge.
- Product knowledge.Technical Writing Skill.
- Statistical and analytical problem solving.
- Advanced Project Management skills.
- Coaching skills
