What are the responsibilities and job description for the Senior Manager, Post Market Surveillance position at Abbott?
The Opportunity
This position works out of our Burlington, MA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
This position of SENIOR MANAGER, POST MARKET SURVEILLANCE works within our Quality team supporting all parts of Abbott Heart Failure. This role has responsibility for complaint handling and is process owner for complaint analysis, regulatory reporting, and complaint management. This role will be the subject matter expert, work closely with Commercial, Operations, and Design teams, and interact with regulatory agencies and customers to ensure the division follows global complaint handling procedures and regulations.
This position is responsible for implementing and maintaining the effectiveness of the quality system including personnel development and assessing performance. Providing direct and indirect supervision to professional, direct or indirect labor staff to ensure that complaints are handled in accordance with global regulations. The position ensures that compliance is maintained and that employees are trained and following the required divisional and Abbott policies and procedures. The Senior Manager communicates with Senior and Executive management in the area of complaints handling and issues affecting product performance and anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues.
What You’ll Work On
Responsible for implementing and maintaining the effectiveness of the quality system.
Identifies and recruits talented staff to support and execute complaint handling activities and on-market support for multiple product lines deemed critical to success of financial performance for the Division.
Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization.
Ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements.
Champions and actively participates in development / improvements of complaint handling processes and procedures.
Responsible for ensuring that customer complaints are reviewed in a timely manner and elevated to the medical events group as necessary to meet reporting regulations.
Responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system.
Monitor incoming complaints for increasing trends and alert management when a product issue is emerging.
Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the data
Work effectively with Customer Service and R&D, as well as other internal and external organizations as needed, to coordinate and facilitate improvements in complaint handling processes.
Works closely with Complaint Investigation, Supplier QA and Operations teams to ensure that exception reports and corrective and preventive actions are conducted as necessary for complaint issues.
Facilitate meetings and discussions across multiple organizations as required to improve / enhance complaint handling processes.
Interacts with Senior and Executive level staff to escalate field compliant issues as necessary.
The incumbent also has a high level of interaction with FDA and global regulatory agencies including routine communication and inspections.
Required Qualifications
Bachelor’s Degree in a related field including Engineering, Life Sciences, Medical / Clinical; or the equivalent combination of education and work experience.
Minimum 10 years of experience in regulated industry healthcare industry (i.e.; Medical Devices, Pharmaceutical, etc.)
Minimum 5 years of experience in Quality roles in a regulated industry
Minimum 4 years of managing / leading organizations
Minimum 2 years of complaint handling experience
Substantial working knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971
Preferred Qualifications
Demonstrated experience building effective organizations and leveraging teams to accomplish projects
Experience with operational Lean, Six Sigma, and Continuous Improvement initiatives
Experience with cardiovascular systems
Advanced degree in the biomedical field
Experience working in a broader enterprise / cross-division organization
Working knowledge of Microsoft Office suite and statistical software
Strong technical writing skills and effective communication skills
