Principal Quality Systems Business Analyst

MedtronicNorthridge, CA
5d

About The Position

The Principal Quality Systems Business Analyst will be working across the Diabetes Quality Function and Technology teams to deliver scalable, flexible Quality Management Systems globally. This role supports quality management systems (QMS) to ensure compliance with FDA, ISO, and other applicable standards. This role is responsible for monitoring, analyzing, and improving quality processes through technology and data tools, driving continuous improvement across the organization. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

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.

Nice To Haves

  • Experience with Veeva, TrackWise, SmartSolve, SAP QM, or other eQMS platforms
  • Medical Device experience
  • IT/Digital Technology expertise

Responsibilities

  • 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 the 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.

Benefits

  • Medtronic offers a competitive Salary and flexible Benefits Package
  • A commitment to our employees lives at the core of our values.
  • We recognize their contributions.
  • They share in the success they help to create.
  • We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
  • 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
  • Simple Steps (global well-being program)
  • 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)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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