The Quality Engineer II plays an integral role in maintaining compliance with global regulations by supporting Post Market Surveillance activities
Job Summary
The Quality Engineer II plays an integral role in maintaining compliance with global regulations by supporting Post Market Surveillance activities.
This position involves collaboration across Quality, Regulatory, Clinical Affairs, and Operations departments to fulfill data requests and deliver detailed analysis.
BD offers a culture where employees are supported to learn, grow, and bring their authentic selves to work, fostering creativity, innovation, and effective problem-solving.
Matching Summary
The Quality Engineer II plays an integral role in maintaining compliance with global regulations by supporting Post Market Surveillance activities.
Skills & Requirements
Must-have
Post Market Surveillance reporting
Quality Engineering tools application
Regulatory compliance with global standards
Statistical and risk assessment techniques
Cross-functional team collaboration
Data analysis and interpretation
Proficient in Microsoft Excel
Nice-to-have
Dashboard development using BI tools
SQL database and data warehouse experience
Strong interpersonal and presentation skills
Problem solving and training delivery
Ability to lead cross functional teams
Knowledge of MasterControl and Power BI
Key Requirements
Bachelor’s or Engineering degree
Minimum four years engineering or quality experience
Medical device experience with Class I, II, and III devices
Understanding of ISO 13485 and ISO 14971
Ability to travel up to 5%
Experience with test method validation and risk assessment