Post-Market Quality Insights Analyst

Vaisesika; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Vaisesika is an ISO 27001 certified innovator in software development and quality engineering, serving healthcare and life sciences sectors. The post-market quality analytics role focuses on data-driven decisions to improve product safety and regulatory compliance.

The candidate will compile and analyze post-market data, lead review boards, and present findings to leadership. Proficiency with Excel, data trends, and statistical methods is essential, along with strong communication across teams.

Qualifications

• Bachelor's degree in a technical field is required.
• Advanced proficiency in Microsoft Excel, including data trending and analysis functions.
• Strong interpersonal and communication skills, with the ability to present findings to all leadership levels.
• Preferred experience in medical device or healthcare industries, including processing complaints.
• Working knowledge of medical device quality system regulations (FDA QMS, ISO 13485).
• Understanding of statistics and data analysis methods to detect trends and support quality decisions.

Responsibilities

• Compile, analyze, and interpret post-market data to detect emerging trends and potential product quality issues.
• Manage and lead recurring Post Market Surveillance Review boards, preparing summaries and presenting findings to key stakeholders.
• Lead projects and initiatives to help the Post-Market Quality team achieve departmental and organizational goals.
• Perform queries and ad hoc analyses on complaints and reported product problems.
• Ensure data is accurate, timely, complete, and relevant, collected through established business processes.
• Identify and recommend process improvements for data trending and analysis methods. Collaborate across teams to provide actionable insights for product quality and risk mitigation.

Skills

Excel

Data analysis

Communication

Statistical methods

Education

Bachelor's degree in a technical field

Job description

Vaisesika is an ISO 27001 certified innovator in software development and quality engineering, serving healthcare and life sciences sectors. The post-market quality analytics role focuses on data-driven decisions to improve product safety and regulatory compliance.

The candidate will compile and analyze post-market data, lead review boards, and present findings to leadership. Proficiency with Excel, data trends, and statistical methods is essential, along with strong communication across teams.