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Senior Quality Engineer

hace 1 mes

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 Engineer (2nd Shift) to be in Juarez, Chih., MX**

**Purpose**:
Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers.

**You will be responsible for**:
Under general direction and in accordance with all applicable federal, state, and local laws/regulations
and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Primary responsibilities include working in Quality Engineering and with other functional groups
in support of new product/process development, quality operations or quality assurance.
- Utilizing Quality Engineering tools/processes in development and implementation of practices for
the effective and efficient development, transfer, and maintenance of products/processes
throughout the product lifecycle.
- Leading efforts with quality improvement opportunities as appropriate to legacy products,
continuous improvement, and customer satisfaction.
- Develop and establish effective quality control and support associated risk management plans.
- Write, review and/or approve process and product validation protocols and reports, equipment
qualifications, engineering change orders.
- Use statistical tools to analyze data, make acceptance decisions, and improve process
capability (Six Sigma, SPC, DOE).
- Determine sterility, biological and packaging test requirements utilizing appropriate industry or
agency standards for new products.
- Ensure that development activities follow design control requirements, product is tested per
applicable standards, European Essential Requirements are met per the MDR, and product is
properly transferred to manufacturing.
- Provide all planning necessary to ensure effective product acceptance. This includes, but is not
limited to, part qualifications, specification development, and sampling plans.
- Support vendor audits as technical lead as needed and support Supplier Quality as Quality
representative as appropriate.
- Initiate and investigate Corrective and Preventative
- Assist Regulatory Affairs in developing submissions for process changes, inspection changes,
and new processes/devices as necessary.
- Participate in design reviews and pre-validation assessments to ensure the safe and
environmentally sound start-up of new processes.
- Makes decisions independently on engineering problems and methods and represents the
organization in conferences to resolve important questions and to plan and coordinate work.
- Consults with supervisor and provide guidance as needed concerning unusual problems and
developments.
- Responsible for one or more of the following as needed:

- Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM,
Quality Operation or Quality Assurance activities.
- In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized
engineering project or a number of small projects with varying levels of complexity.
- As an individual researcher, carries out assignments requiring the development of new
or improved