Manager, Complaint Handling

Abbott Laboratories • Alameda, CA

9d • $114,000 - $228,000

About The Position

The incumbent is responsible for managing all aspects of the Complaint Handling process. This includes managing complaint evaluation and complaint closure resources to meet division goals for complaint metrics and identifying opportunities for improvement and/or better efficiency in complaint handling processes. Incumbent is also responsible for monitoring and communicating metrics regarding the quality of the complaint evaluation and investigation documentation. Serve as a Complaint Handling process subject matter expert during audits, inspections, and assessments by regulatory authorities. Collaborate with internal and external partners to ensure call registration, complaint evaluation, and case closure adhere to global regulations and divisional procedures while developing team capability and ensuring training and compliance.
This position is responsible for personnel development and assessing performance. Provides direct and indirect supervision to staff to ensure that complaints are handled in accordance with global regulations.

Requirements

• Bachelor’s degree in Biomedical Engineering, Nursing, or a related field, with at least 6 years of experience in medical devices and a minimum of 3 years of team management; an equivalent combination of education and relevant professional experience will also be considered.
• Strong leadership and strategic planning skills, with the ability to manage teams, enhance processes, prioritize tasks, forecast milestones, and manage budgets.
• Solid understanding of domestic and international medical device regulations, including FDA requirements, and the ability to follow company procedures and compliance standards.
• Excellent verbal/written communication, analytical problem‑solving, negotiation, interpersonal, and presentation skills, with the ability to communicate effectively across multiple levels of the organization.
• Strong organizational and follow‑up skills, ability to multitask in a fast‑paced environment, and hold others accountable.
• Ability to work effectively in a team, maintain regular and predictable attendance, and travel 5–25% (including internationally).

Nice To Haves

• Demonstrated personal computer skills including spreadsheet skills, word processing, database management and other relevant project management applications.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Responsibilities

• Ensures the handling of all complaints as required by applicable regulations, before or by their due date.
• Identifies and implements proactive strategies and metrics to ensure timeliness of complaint handling activities. Seeks out and implements ways to accomplish higher quality deliverables, more efficiently. Tracks and ensures timely review of a high volume of reports and source documents.
• Accountable for staff development; provides feedback, instructs, mentors, evaluates, and coaches. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus. Models optimum leadership competencies to inspire an energized, empowered and accountable work force.
• Creates an environment that consistently fosters employee understanding of quality and motivates all employees to actively participate in the process of continuous quality improvement.
• Trains or coordinates training for staff in complaint handling
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities as assigned.

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