Ingeniero de Calidad Senior - Tercer Turno

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Ciudad Juarez, Chihuahua, Mexico, MX301 – Circuito Interior Norte - BWI

Job Description:

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:

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 standa...