Senior MDR/Vigilance Specialist:
Company: Medtronic
Job Type: Full Time
Location: Hybrid - Northridge, California, United States of America
Posted On: 8 Days Ago
Application Deadline: June 24, 2025
Job Overview:
The Senior MDR/Vigilance Specialist at Medtronic is responsible for monitoring all complaints within the Diabetes Business Unit, ensuring quality compliance, and supporting complaint analysis, Medical Device Reporting (MDR), and FDA adverse event reporting requirements. This role also involves supporting CAPA planning and implementation, conducting root cause analysis, and navigating industry regulations like FDA QSR and ISO standards.
Responsibilities:
Complaint Analysis & MDR: Ensure complaints are within specifications and compliance with FDA adverse event reporting and Good Documentation Practices (GDP).
Investigations & Root Cause Analysis: Coordinate complaint and product failure investigations, including pre- and post-market root cause analysis and responses to regulatory inquiries.
Continuous Improvement: Apply process improvement tools such as DMAIC methodology, 5 Why’s, Root Cause Analysis, and Fishbone diagrams to enhance quality management processes.
Regulatory Compliance: Ensure compliance with FDA QSR (21 CFR part 820, 803 & 806), ISO-13485, ISO-14971, and ISO 9001.
CAPA & Risk Assessment: Support CAPA planning, implementation, and risk assessments including PFMEA and Product Hazard Analysis.
Process Improvement: Utilize Lean manufacturing and Six Sigma methodologies to improve product and complaint handling processes.
Basic Qualifications:
Education:
Master’s degree or foreign equivalent in Nursing, Biology, Industrial or Biomedical Engineering, Industrial & Technical Studies, or a related field with 2 years of experience in a related role, or
Bachelor’s degree or foreign equivalent in the same fields with 5 years of relevant experience.
Experience:
At least 2 years of experience with MDR and complaint handling, FDA adverse event reporting, GDP, and regulatory inquiries.
Experience with Lean manufacturing, Six Sigma methodologies, CAPA planning, and Risk Assessment.
Familiarity with FDA QSR (21 CFR part 820, 803 & 806), ISO-13485, ISO-14971, and ISO 9001.
Salary Range:
$110,600 to $153,600 per year
Benefits & Compensation:
Medtronic offers a competitive salary, a wide range of benefits including health, dental, and vision insurance, 401(k) plans, paid time off, and more.
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