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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Systems, specifically in nonconformance and CAPA processes, with a strong focus on regulatory compliance and continuous improvement. Proven ability to lead global projects and teams while providing quality and technical consulting across the Medical Device, Pharmaceutical, and Nutritional industries.
Highest-signal resume keywords
Nonconformance ManagementCAPA ProcessesQuality AssuranceRegulatory ComplianceProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Root Cause AnalysisQuality System Continuous ImprovementRisk ManagementComplaint ManagementDesign ControlsValidationData AnalysisTraining DevelopmentQuality Data MonitoringIndustry Standards Knowledge
Soft Skills
LeadershipCoachingCommunicationCollaborationAccountability
Industry Keywords
Medical DevicePharmaceuticalNutritionalRegulated IndustryGlobal RegulationsQuality Management SystemBest PracticesContinuous Improvement InitiativesExecutive Management InteractionIndustry Groups Participation
About the role
Key responsibilities & impact- Provide corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes
- Support Abbott Businesses/Divisions with quality and technical expertise and consulting activities globally
- Lead global committees and teams to achieve quality systems objectives
- Lead training, evaluate business application effectiveness of nonconformance/CAPA processes, and implement requirements into the corporate-wide quality management system
- Act as corporate liaison and subject matter expert for nonconformance, investigation, and CAPA elements
- Monitor regulatory requirements, best practices, and regulatory agency expectations
- Participate in industry groups related to the subject matter
- Improve Quality Systems through monitoring, trending, and analyzing quality data and industry intelligence
- Drive best-practice methods through remediation, training, coaching, and continuous improvement initiatives
- Manage multiple global projects, including leadership of the Nonconformance and CAPA community of practice
- Lead and participate in analysis of nonconformance and CAPA quality data and assessments
- Manage confidential information across project lifecycles
- Interact significantly with executive management and maintain accountability for assigned projects
Requirements
What you’ll need- Bachelor’s Degree required; Life or Engineering Sciences discipline preferred
- 10+ years of overall experience
- 6 years in nonconformance and CAPA processes, root cause analysis tools, and quality system continuous improvement experience in a regulated industry
- 4 years in Quality Assurance and/or Compliance, managerial, supervisory or SME role
- 10+ years in Medical Device, Pharmaceutical and/or Nutritional industry professional-level position
- 3 years of project management experience
- 10–12 years of total combined minimum industry experience required
- Working knowledge of global regulations and industry standards related to nonconformance, investigation, and CAPA processes
- Working knowledge of related Quality System elements, including management responsibility, risk management, complaint management, design controls, and validation
- Willingness to travel 50% of the time
Benefits
Comp & perks- Career development with an international company
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit
- Access to health and wellness benefits
