Jobot Consulting is seeking a Sr. Analyst Field Assurance- Neurovascular Devices to join their team remotely. The role involves leading field assurance activities to ensure the quality and safety of neurovascular medical devices.
About the Role
As a Sr. Analyst for Field Assurance, you will lead activities related to neurovascular devices, including identifying and evaluating product issues, conducting risk assessments, and developing corrective actions. You will collaborate with cross-functional teams, ensure regulatory compliance, and provide technical guidance. Your role also includes participating in audits and preparing reports for senior management.
About You
Required:
Bachelor's degree in Engineering, Life Sciences, or a related field.
Minimum of 5 years' experience in the medical device industry, focusing on cardiovascular and neurology devices.
Strong knowledge of FDA, ISO, and MDR regulations.
Proven experience in risk management and root cause analysis.
Excellent analytical and problem-solving skills.
Strong communication skills.
Proficiency in statistical analysis and data interpretation.
Preferred:
Master's degree or higher.
Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.