Manager, Quality Manager - CAPA

This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location. The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting/vigilance and product actions (corrections and removals), as well as supporting other Abbott Quality System elements as it relates to post market surveillance

• Use established management skills to lead global committees and teams to achieve quality, regulatory compliance, and business objectives
• Act as the corporate liaison to Abbott Businesses/Divisions and provide support as an expert in the subject matter of complaints management, product actions, and medical device reporting
• Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures as appropriate
• Improve the effectiveness of Abbott’s Quality Systems through monitoring, trending and analyzing of quality data and industry intelligence information
• Act as a change agent for incorporating best practice methods through business support activities such as remediation, training, coaching, etc.

• Bachelor’s Degree required; Life or Engineering Sciences discipline, preferred
• Overall 10+ years of experience with 6 years in Complaint Management and/or Corrections and removals experience in a regulated industry required
• 4 years in Quality Assurance and/or Compliance, managerial, supervisory or SME role; 6+ years in Medical Device, Pharmaceutical and/or Nutritional industry professional-level position
• External regulatory experience in product actions (corrections and removals) or medical device reporting desired

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit
• 401k matching
• Health insurance
• Flight privileges

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines