Hybrid Principal Quality Systems Business Analyst

Posted 3 weeks ago

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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 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

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

Benefits

  • 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)

Job title

Principal Quality Systems Business Analyst

Job type

Experience level

Lead

Salary

$112,800 - $169,200 per year

Degree requirement

Bachelor's Degree

Location requirements

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