Business Analyst driving complex analysis initiatives at Saab, collaborating with stakeholders and ensuring structured requirements. Leading workshops for improved operational methods and high delivery quality.
About the role
- Principal Quality Systems Business Analyst collaborating with multiple teams to improve quality processes for Medtronic's Diabetes business. Involves managing quality systems, compliance, and continuous improvement projects.
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
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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