Senior MDR/Vigilance Specialist (Finance)

We anticipate the application window for this opening will close on - 24 Jun 2025

Position Description:

Sr. MDR/Vigilance Specialist for Medtronic, Inc., located in Northridge, CA. Responsible for monitoring all the complaints in Diabetes Business Unit by supporting and ensuring the quality of complaints are within the specifications, and in compliance, which includes Complaint analysis activities, Medical Device Reporting (MDR) and complaint handling to include FDA adverse event reporting requirements and Good Documentation Practices (GDP). Coordinate Complaint and Product Failure Investigations and pre and post market root cause analysis, and responses to regulatory inquiries. Responsible for continuous improvement activities and problem-solving skills for the Diabetes Customer Quality Experience Management team by leveraging process improvement tools to include DMAIC methodology, 5 Why's, Root Cause Analysis, and Fishbone diagrams. Utilize Lean manufacturing and Six Sigma methodologies. Navigate various government and industry regulations including FDA Quality System Regulations (QSR) 21 CFR part 820, 803 & 806, ISO-13485, ISO-14971 and ISO 9001. Support and coordinate CAPA (Corrective and Preventive Action) planning and implementation. Responsible for determining Risk Assessments, Process Failure Mode Effects Analysis (PFMEA) and Product Hazard Analysis. #LI-DNI

Basic Qualifications:

Requires a Master's degree or foreign equivalent in Nursing, Biology, Industrial or Biomedical Engineering, Industrial & Technical Studies or related field and two (2) years of experience as a Consumer Affairs Specialist, Medical Device Reporting Compliance Specialist or related occupation; or Bachelor's degree or foreign equivalent in Nursing, Biology, Industrial or Biomedical Engineering, Industrial & Technical Studies or related field and five (5) years of experience as a Consumer Affairs Specialist, Medical Device Reporting Compliance Specialist or related occupation. Must possess at least two (2) years of experience with each of the following: MDR and complaint handling, FDA adverse event reporting requirement, and GDP; Complaint and Product Failure Investigations, pre and post market root cause analysis, and responses to regulatory inquiries; DMAIC methodology, 5 Why's, Root Cause Analysis and Fishbone Diagrams; Lean manufacturing and Six Sigma methodologies; FDA QSR 21 CFR part 820, 803 & 806, ISO-13485, ISO-14971 and ISO 9001; CAPA planning and implementation; and Risk Assessment, PFMEA, and Product Hazard Analysis.

Salary: $110,600 to $153,600 per year

#LI-DNI

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans