**Job Function**:
Quality
**Job Sub Function**:
Quality Assurance
**Job Category**:
Professional
**All Job Posting Locations**:
Ciudad Juarez, Mexico
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
**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.
- Determines the effectiveness of these techniques in the previously implemented improvements.
- Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and risk analysis documentation such as FMEA of the process given the changes in the product/process.
**Qualifications / Requirements**:
- Bachelor’s in engineering: Mechanical, Electrical, Industrial or applicable science.
- 0 to 2 years of work experience or demonstrated performance
- Statistics knowledge
- Use of computer packages.
- Ability to communicate in English, orally and in writing.
- Knowledge of engineering fundaments.
- Knowledge of the Product Risk Management / process (FDA and ISO regulations) is preferable.
- Ability to perform “active involvement” in the solution of problems and resolution problems, preferable. Capacity to solve problems by providing good judgment, highly desired.
- CQA certification (preferably

📌 Quality Engineer (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez