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 jnj.com.
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, 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 Sr Quality Engineer 2nd shift 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.
- Consults with supervisor and provide guidance as needed concerning unusual problems and developments.
- Responsible for one or more of the following as needed:
- Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM, Quality Operation or Quality Assurance activities.
- In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering project or a number of small projects with varying levels of complexity.
- As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures.
- Work is expected to result in the development of new or improved techniques or procedures.
- Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods.
- Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable
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.
- Ability to apply project management skills to ensure fulfillment of new product development requirements.
- 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:
Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy