Principal Quality Systems Business Analyst
Medtronic
full-time
Posted on:
Location Type: Office
Location: Northridge • California, Minnesota, Texas • 🇺🇸 United States
Visit company websiteSalary
💰 $112,800 - $169,200 per year
Job Level
Lead
About the role
- Maintain and support the company’s electronic quality management system (eQMS)
- Monitor and analyze quality system metrics, identifying trends and opportunities for improvement
- Assist with management of quality system processes including CAPA, complaints, nonconformances, internal audits, training, and document control
- Generate reports and dashboards to support compliance monitoring and management reviews
- Ensure timely and compliant documentation and record-keeping in accordance with FDA and ISO requirements
- Participate in internal and external audits, providing data and system support
- Collaborate with cross-functional teams to support quality initiatives and continuous improvement projects
- Support change management and system updates to maintain compliance and usability
Requirements
- Requires 7+ years of experience with a Bachelor’s Degree or 5+ years of experience with an advanced degree or 12+ years of experience with a High School Diploma or equivalent.
- Experience with eQMS platforms (Veeva, TrackWise, SmartSolve, SAP QM) or other eQMS platforms
- Medical Device experience
- IT/Digital Technology expertise
- Knowledge of FDA, ISO, and other applicable standards
- Experience managing quality system processes including CAPA, complaints, nonconformances, internal audits, training, and document control
- Experience generating reports and dashboards to support compliance monitoring and management reviews
- Experience participating in internal and external audits
- Ability to collaborate with cross-functional teams and support change management
Benefits
- Competitive Salary and flexible Benefits Package
- Short-term incentive (Medtronic Incentive Plan - MIP)
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Short-term disability
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
- Paid sick time for temporary employees
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
eQMSCAPAcomplaints managementnonconformance managementinternal auditsdocument controlreport generationdashboard creationcompliance monitoringchange management
Soft skills
collaborationcontinuous improvementdata analysistrend identificationproblem-solvingcommunicationorganizational skillsteam supportadaptabilityleadership