Staff Specialist, Product Surveillance at Abbott Laboratories

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 114,000 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 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 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 Staff Specialist 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 Clinical Review and Decision making of complaints for Class III Medical Devices

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Identifies and recruits staffing / resources to support complaint handling activities and on-market support for multiple product lines deemed critical to success and financial performance for the Division.

• Develops staff and builds high achieving teams to support business objectives and meet requirements of changing regulations.

• 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. Ensures evaluations are completed in a timely manner with a high degree of accuracy. Elevates 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 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 Field Clinical Specialists, Commercial Organization, Customer Service, R&D, as well as other internal and external organizations as needed, to coordinate and facilitate execution of the complaint handling process.

• Works closely with Complaint File Managers, Complaint Investigators, 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 Nursing, Pre-Med, Engineering, Life Sciences; or the equivalent combination of education and work experience.

• Minimum 8 years of experience in Medical Device Quality/Engineering or Health Care Clinical roles in a regulated industry (i.e.; Nursing, Class III Medical Devices, Pharmaceutical, etc.)

• Minimum 3 years of experience in a supervisory role or related position of leadership

Preferred Qualifications

• Experience as a healthcare provider in any of the following environments: Intensive Care (ICU), Post Surgery (PACU), VAD / Cath Labs, Cardiac Medical Surgical, or other related

• Demonstrated experience building effective organizations and leveraging teams to accomplish goals and projects

• Experience with operational Lean, Six Sigma, and Continuous Improvement initiatives

• Experience with cardiovascular systems

• Nursing, Medical, or Advanced Engineering/Science degree in the biomedical field

• Experience working in a broader enterprise/cross-division organization

• Working knowledge of relevant industry regulations and standards including: CFR 803, CFR 806, CFR 820, ISO 13485, ISO 14971

• Working knowledge of Microsoft Office suite and statistical software

• Strong technical writing skills and effective communication skills

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.