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)
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