Staff Source Quality Engineer

hace 3 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

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 Source Quality Engineer to be in Ciudad Juarez, Mx.**

**Purpose**:The Source Quality Engineers are responsible for supplier-related quality engineering activities in support of New Product Development and ongoing manufacturing. Source Quality Engineers have the opportunity to support activities associated with External Manufacturers, Direct Material (Component) Suppliers, and Indirect Service Suppliers.

**You will be responsible for**:
Responsibilities of the Staff Source Quality Engineer may include the following:

- Issues resolution with suppliers - investigating challenging issues with significant business impact.
- Developing and maintaining suppliers - executing Supplier Business Reviews, audit related activities and deep dive Technical Assessments at suppliers.
- Development/negotiation of Quality Agreements with suppliers.
- Changing the way we do business - continuously improving our policies and procedures.
- Supplier process changes - assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities).
- Stabilizing new products at suppliers - working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre
- and post-launch activities.
- The Staff Source Quality Engineer will act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
- They will provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product.
- The Staff Source Quality Engineer will also provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements.

**Qualifications** Qualifications and requirements**:

- Bachelor's degree is required comparable work experience, or a related field is an asset.
- 6 years Quality/Manufacturing experience or related experience is required.
- It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc.
- Strong root cause analysis skills are required.
- Strong English language skills are required.
- Ability to travel to US suppliers and sites is required
- Experience in the medical device, pharmaceutical or other highly regulated industry is preferred.
- Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is preferred. An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred..
- Auditing experience is preferred. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred.

**Primary Location**
Mexico-Chihuahua-Juarez
- **Organization**
E.E.S., S.A. de C.V. Mexico (8283)

**Job Function**
Engineering

**Requisition ID**
2206082205W

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