Manager, Quality Manager - Complaints

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.

WHAT YOU’LL DO

• 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.

POSITION ACCOUNTABILITY / SCOPE :

Required Qualifications

The base pay for this position is $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.