Senior Quality Engineer

hace 6 meses

Ciudad Juarez, México Johnson & Johnson A tiempo completo

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 QUALITY ENGINNER to be in Ciudad Juarez, Mx.**

**Job Summary**:
The Quality Engineer Senior plans, conducts and directs engineering projects or studies including complete projects that require advanced knowledge in specialized field. He/she applies a wide and diverse knowledge of the engineering principles and practices within the assigned areas. He/she can coordinate and direct personnel activities of technical support and is responsible of the technical development of the personnel assigned. The Quality Engineer Senior will use quality engineering tools and practices for the effective and efficient development of transfers and the maintenance of products / processes in the complete life cycle of the product. The position holder will also use quality engineering principles and investigation skills and problem resolution to improve and maintain the products / processes that are aligned with quality and the business global vision. He/she will the appropriate risk management to prevent unforeseen failure modes and improve the capacity of the processes. This person will support the business processes.

**Duties & Responsibilities**:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
- Performs benchmarking to develop more effective methods to improve quality.
- Support the development of quality engineering and compliance of the quality with the adequate abilities for the introduction of new products, and management of the life cycle of the product.
- Revises and approves engineering change orders. (ECOs). Compliance / Regulatory
- Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.
- Participates in the preparations activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
- Responds to internal or external audit observations related to the quality engineering function.
- Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
- Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
- New products / Process Introduction
- Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments in order to develop, conduct and approve validation. New Products / Process Introduction
- Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies of products and processes. Product Quality, Control and Disposition and Performance Standards
- Directs and attends to NCs Revisions meetings as a member of MRB.
- Conducts and supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applicable.
- Provides support in the analysis of products related to customer complaints, to determine failure modes.
- Analyze / check the effectiveness of preventive and corrective actions.
- Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
- Provides support in the resolution of complex problems (technical

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