Supervisor, Post Market Surveillance

AbbottBurlington, MA
$78,000 - $156,000Onsite

About The Position

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. The individual is responsible for providing the direct supervision of employees in the Complaint Handling Group who evaluate, process and / or close complaint cases from customers. Supervision includes the assigning and monitoring of weekly caseloads to Product Surveillance Analysts, coaching and counseling team members, and conducting formal and informal performance evaluations. The incumbent is expected to understand all aspects of the complaint handling process, manage resources to meet division goals for complaint metrics, and identify opportunities for improvement and/or better efficiencies in our complaint handling processes. Incumbent is also responsible for monitoring and communicating metrics regarding the quality of the complaint evaluation and investigation documentation performed by their direct reports.

Requirements

  • Bachelor's degree in related discipline or an equivalent combination of education and work experience
  • 4+ years of related work experience
  • Previous experience with complaint investigations and evaluations in a regulated environment required
  • An understanding of the product use is helpful
  • Must be able to effectively lead and manage a large staff of non-exempt employees including full-time and contract workers.
  • Excellent communication skills are required as there is frequent interaction with other functions in Division such as Customer Support, Medical Events Group, and Complaint Evaluations Group.
  • Must also be able to act autonomously, make decisions and give direction regarding the need to forward complaints for additional documentation, investigation and / or processing vs. processing complaint for closure.

Nice To Haves

  • 2+ years supervisor role
  • 2+ years Post-Marker Surveillance experience
  • Must be able to effectively lead and manage employees including full-time and contract workers.
  • Excellent communication skills are required as there is frequent interaction with other functions such as Customer Support, Field Team, Manufacturing and R&D.
  • Must also be able to act autonomously, make decisions and give direction regarding the need to forward complaints for additional documentation, investigation and / or processing vs. processing complaint for closure.

Responsibilities

  • Gather and prepare trend information and recommend areas of focus.
  • Assist in the development of the capital plan by identifying projects to improve processes, reduce costs, and maintain operations.
  • Sets standards and monitors staff performance; provide performance feedback; write and conduct appraisals for employees, recommend merit increases and promotions, deliver rewards and sanctions.
  • Manages assigned projects; work cross functionally to identify changes and necessary resources.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Regularly makes decisions which impact quality, time and/or cost; timely decisions are required regarding issues such as to proceed or abort, work OT, etc.
  • Bases decisions on the overall good, rather than on benefit to a particular functional area, serves as a champion for specific projects and initiatives.
  • Interact with peers in operations and within other cross-functional groups.
  • Responds directly to on-site requests for information from internal and external regulatory agencies.
  • Tracks and reviews daily indices (e.g., line outputs, labor efficiency, reject rates) and regulatory requirements to identity gaps between current and desired performance, applies standard problem-solving tools (e.g., fish bone diagrams, Pareto analysis), recommends and implements corrective action so that the impact of the problem is minimized.
  • Interfaces with other areas to identify and solve problems.
  • Recognizes risk relative to procedures and takes appropriate action.
  • Identifies and quantifies the financial, quality, regulatory, and human considerations associated with decisions.
  • Adapts to and supports change in a timely, positive manner.
  • Identifies and communicates need for change.
  • Contributes to the creation of the team's mission, objectives, and strategies, accepts team decisions, and works toward their implementation.
  • Establishes and supports the norms and conditions for a work environment that supports team productivity, draws on the strengths of each team member, seeks input of team members, works cross functionally to resolve issues.
  • Utilizes information from seminars, bench marking, focus groups, etc., to identify trends and generate recommendations for continuous process improvements in such areas as reduced costs, new technologies, and reject rates.
  • Follows through on promises and commitments and maintains confidences.
  • Controls emotional reactions; copes with stress; is open to others' ideas; demonstrates an understanding and appreciation of differences in others; treats others as individuals with unique skills, interests and values; seeks to understand the goals and needs of others.
  • Promotes productivity and morale by treating others with respect and dignity.
  • Listens to different points of view, taking ownership and responsibility for own actions.
  • Displays consistency between words and actions; follows through on commitments; is available to answer questions.
  • Provide constructive feedback on individual and team accomplishments in a timely and non-threatening manner.
  • Raises issues that block the achievement of individual and team performance; voices opinions and concerns without waiting to be asked; communicates through areas of difference as well as areas of common issues, i.e., can talk about both sides of an issue.
  • Lead teams to customer-oriented solutions that make business sense.
  • Demonstrates awareness of the changing competitive, technological, health care, and regulatory environments, and demonstrates a perspective beyond one's own function.
  • Makes plans to accomplish assigned daily activities and simple projects; establishes priorities so as to handle competing demands; optimizes use of available resources; estimates time and resources necessary to complete daily tasks or projects; establishes follow up systems.
  • Influences others to support a course of action and to incorporate quality concepts in all activities, appropriately uses authority, influences activities without reliance on formal authority, and communicates unpopular decisions in a realistic but favorable light.
  • Makes timely decisions which consider the facts and data at hand; champions specific projects; knows when to delegate to teams or other levels.
  • Adjusts communication style and medium (oral, written, or electronic) to meet the needs of the receiver (direct reports, peers, customers, managers); summarizes data and distills it down to relevant points to enhance understanding; uses appropriate level of language and detail for the receiver.

Benefits

  • 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.
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