Quality Analyst II

Job Description

An employer is seeking a Quality Analyst II for a remote long term opportunity with a leader in the medical device industry. This quality analyst the Post Market Surveillance (PMS) organization through advanced statistical analysis, software validation, data visualization, and process optimization efforts. This individual will analyze post-market product data, develop and maintain analytical tools, create regulatory and management reporting, and support ongoing quality and compliance initiatives across Medical device business units. The ideal candidate combines strong technical expertise in R programming, data analytics, software validation, and database querying with a background in quality systems and medical device or regulated environments.

Key Responsibilities will include: review and analyze post-market surveillance data across multiple product lines to identify trends, quality signals, and emerging risks. Develop, maintain, and enhance statistical models, computational scripts, and analytical tools using R and the Tidyverse ecosystem. Design and build interactive dashboards and reporting solutions using R Shiny and advanced data visualization techniques. Generate monthly complaint trending reports and other post-market surveillance deliverables for leadership review.

Support signal detection activities through statistical analysis and presentation of findings to stakeholders.

Execute ad hoc statistical analyses and reporting requests to support quality, regulatory, and business needs.

Participate in software validation activities, including protocol development, testing, documentation, and compliance support. Create and maintain SQL queries to extract, transform, and validate data from enterprise systems. Utilize advanced Excel functionality for data analysis, validation, reporting, and process improvement initiatives. Manage project activities and documentation within Jira, ensuring deliverables and timelines are met.

Collaborate with Quality, Regulatory Affairs, Data Science, and business stakeholders to improve surveillance processes and reporting capabilities. Support continuous improvement initiatives by identifying opportunities for automation, standardization, and enhanced data-driven decision making.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Advanced proficiency in R Programming

Strong experience with the Tidyverse ecosystem

Experience developing applications and dashboards using R Shiny

Data visualization and statistical reporting expertise

Experience supporting Software Validation activities in a regulated environment

Advanced Microsoft Excel skills, including complex formulas, pivots, data modeling, and reporting

SQL development and data querying experience

Experience using Jira for project tracking and workflow management