Manager, Quality Manager - CAPA

Abbott Laboratories • Lewes, DE

7d

About The Position

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. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location.
What You’ll Work On
Our location in Lake Bluff, IL currently has an opportunity for a Program Quality Manager in Complaints, Vigilance and Product Actions.
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. This includes but is not limited to providing global support to Abbott Businesses/Divisions, subject matter expertise, training, and consultation on regulatory and compliance strategy and application. The incumbent must have a working knowledge of global regulations and industry standards, especially as the relate to complaint management, recalls, and medical device reporting. The incumbent should also have knowledge of related Quality System elements, e.g., Vigilance Reporting, Risk Management, Nonconformances & CAPA, etc.

Requirements

• 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

Responsibilities

• 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.
• Participate in industry groups related to the subject matter areas of responsibility.
• 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.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees