Ingeniero de Calidad II - 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:

Under general supervision, participate in new and sustaining 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.

Supports quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product.

Will receive technical guidance on complex problems, but independently develops approaches and solutions.

Work is usually well defined and is checked for progress and reviewed for accuracy upon completion.

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 assisting in a supporting role on new product development, sustaining and supply chain quality projects.

Assist in the development of effective quality control and associated risk management plans.


* Write 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).


* Help to 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 support in quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction


* Assist in planning necessary to ensure effective product acceptance.

This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.


* Support vendor audits as technical lead as needed and support Supplier Quality...