Senior Source Quality Engineer

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.

Diversity, Equity & 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.

We are searching for the best talent for Senior Source Quality Engineer to be in Juarez, Chih.Plant

Purpose:
The Senior Supplier Quality Engineer (Sr. SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Sr. SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the CSS franchise. He/she leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain

You will be responsible for:
Calificaciones - Externas

Provide timely business support for the assigned CSS Supplier Quality Management

(SQM) function globally.
- Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
- Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of Supplier Quality Manager and/or management representative.
- Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
- Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
- Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
- Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
- Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
- Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.
- Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Actively participates in discussions to drive resolution

**Qualifications**:

- A minimum of a bachelor’s degree in Engineering, an Applied Science or a related technical and quality field is required.
- A minimum of 4 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.
- Prior manufacturing, plant or technical background is required.
- Working experience in good manufacturing practice regulated environment is preferred(medical device, pharmaceutical, etc.).
- Demonstrated knowledge of manufacturing principles and practices, and procedures.
- Direct experience in plant and/or supplier GMP auditing is preferred.
- Broad experience with quality systems, including but not limited to validation, non[1] conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required.
- Experience with documentation and technical writing skills, in a regulated compliance environment, is required.
- Component Qualification/Process Validation experience is preferred. New product introduction experience is desired.
- Prior experience with FDA inspections is desirable.
- Broad knowledge of Quality System Regulations and Supplier Quality Management principles are desired.
- Demonstrated ability to id