The Quality Engineer II supports Post Market Surveillance activities through the collection, analyses, trending, and reporting on safety data to proactively identify potential adverse safety risks or performance trends
Job Summary
The Quality Engineer II supports Post Market Surveillance activities through the collection, analyses, trending, and reporting on safety data to proactively identify potential adverse safety risks or performance trends.
This position plays an integral role in maintaining compliance with global regulations, collaborating with cross-functional team members to ensure compliance to applicable regulations, standards, and company policies/procedures.
BD is one of the largest global medical technology companies in the world, aiming to advance the world of health by finding transformative solutions and believing the human element across global teams allows for continuous evolution.
Matching Summary
The Quality Engineer II supports Post Market Surveillance activities through the collection, analyses, trending, and reporting on safety data to proactively identify potential adverse safety risks or performance trends.
Skills & Requirements
Must-have
Post Market Surveillance reporting
Analyze and interpret PMS data
Identify and escalate product issues
Maintain PMS processes compliance
Cross-functional collaboration
Medical device experience Class I, II, III
Nice-to-have
Develop and maintain dashboards
Team-oriented, fast-paced environment
Proactively identify risks
Continuous learning and improvement culture
Key Requirements
Bachelor's degree in Engineering or technical field
Minimum four years engineering/Quality engineering experience
Experience in medical device or pharmaceutical industry
Knowledge of ISO 13485, ISO 14971
Proficient in Microsoft Office Suite (Excel, PowerPoint)