Quality Engineer

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, Mexico

Job Description:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Quality Engineer to be in Juarez City.

You will be responsible for:


* Revision / analysis of the effectiveness of problem resolution techniques such as (PCDA), Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.


* 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 scheduled internal and external audits.


* Participates in quality readiness and in activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).


* Responds to internal or external audit observations related to the function of quality engineering.


* Establishes and properly maintains the required documentation of quality engineering activities and/or quality systems.


* Performs periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS.

Checks the audits results of the area ton ensure that the corrective and preventive actions are adequate


* approves, executes IQ, OQ, PQ, TMV or Software Validation.


* Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.


* Provides support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.


* Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level.


* Evaluates and interprets common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits.


* Evaluates the needs of risk mitigation techniques given the classification of the product, potential types of defects, defect frequency, severity, risk to the patient, process capacity, process control, etc.
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