Senior Quality Engineer

hace 6 días

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 Senior Quality Engineer to be in Ciudad Juarez, Mex.**

**Purpose**: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 improvethe capacity of the processes. This person will support the business processes.

**You will be responsible for**:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Business Improvement
- 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 andcompliance 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 currentproducts 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 problemswhen 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 co

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