01 ago
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Johnson & Johnson
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Ciudad Juárez
01 ago
Johnson & Johnson
Ciudad Juárez
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**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.**
**Purpose**:
- 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 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.
**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.
- 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.
**Required Skills**:
**Preferred Skills**:
📌 Senior Quality Engineer (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez