**Job Function**:
Quality
**Job Sub Function**:
Quality Assurance
**Job Category**:
Professional
**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, 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 Sr Quality Engineer to be in Juarez City.**
**You will be responsible for**:
- 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
- Appendix I Rev M CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5
- 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 Actions (CAPA) as appropriate.
- Assist in complaint analysis as appropriate.
- 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.
**Qualifications / Requirements**:
- Bachelor’s degree in a related field, along with a minimum of 4 - 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master’s degree is preferred
- American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
- Knowledge of GD&T; (Geometric Dimensioning and Tolerancing) is desirable
- Ability to develop and implement Quality standards.
- Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
- Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V;) tools and methodologies.
- Demonstrated auditing and problem-solving skills.
- Understanding of Six Sigma and Business Excellence tools and methodologies. Lean manufacturing experience desirable.
- Ability to train and mentor a diverse array of employees on quality topics.
- Good understanding of theoretical** and practical fundamentals and experimental engineering techniques

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