Post Market Surveillance Quality Engineer Ii

hace 2 semanas

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.


Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.


At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.


In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.

We are in this for life.

We are changing the trajectory of human health, YOU CAN TOO.

We are searching for the best talent for Post Market Surveillance Quality Engineer II to be in Ciudad Juarez, Mx.**
Purpose:As an PMS Engineer, you will be responsible for analyzing the large post market datasets to support analysis and identification of post market quality issues The PMS Engineer will collaborate with a team of engineers, data scientists, statisticians and clinicians to support routine and ad hoc post market surveillance processes (e.g. complaint trending, quality system documentation, corrective action, audit, documentation, analytics etc.)

You will be responsible for:

  • Performing data analysis of the large and sophisticated post market medical device data sets (analytical, preprocessing, categorization, text mining, data science, statistical etc.);
  • Analyzes datasets which include but are not limited to: product complaints, product malfunctions, adverse events, capital equipment service records, clinical reviews, companysponsored funded registries, external registries and databases, post market studies, literature reviews etc.;
  • Incorporating technical skills (analytical, statistical, data visualization, communication etc.) to lead and draw insights from post market and related datasets, build polished presentations and drive product quality and safety related discussions.
  • Analyzing and writing Post Market Surveillance Plans and Reports on a regular basis. Maintain an on time report schedule and conducting ad hoc reports as neededWorking individually or collaborating with other Post Market Surveillance team members for continuous process improvements to challenge the status quo of the post market surveillance processes (e.g. medical device/procedure customization, documentation processes, data analysis automation and visualization, statistical techniques, metrics, statistical modeling, data science, data management etc.);
  • Managing crossfunctional and multilevel collaborators to address post market surveillance requirements in a fastpaced and dynamic environment (e.g. Health authority requests, internal/external audits, field actions, CAPA, complaint handling, nonconformance, clinical studies, medical safety inquiries, manufacturing, statistical analysis etc.);
  • Participates and leads projects under general supervision to improve and develop the sensitivity, specificity and adaptability of the post market surveillance analytical and data management processes.

Qualifications:

Qualifications and requirements:

  • A Bachelor of Science degree in a technical or clinical field.
  • Master's degree preferred.
  • A minimum of 2 years of relevant work experience is required.
  • Shown understanding of statistical concepts is required;
  • Ability to analyze and summarize large data sets is required;
  • Ability to prepare data analysis results for presentations and discussions (e.g. Excel datasets, graphs, charts, slides,.html etc.) is required.
  • Capacity to balance multiple priorities and work with management and partners to prioritize is preferred;
  • Ability to analyze data using the R Software language is preferred;
  • Ability to work efficiently with general or limited supervision, selflearn, and selfseek solutions is preferred;
  • Quality System and Medical Device experience preferred

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