Postmarket Surveillance Analyst I

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 115,000 colleagues serve people in more than 160 countries.

About the role

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Postmarket Surveillance Analyst will analyze quality standards for components, materials or services.

Responsibilities

• Apply quality principles, analyze quality records, prepare reports and recommend improvements.
• Conduct inspection, verification and validation of components or materials used in development processes.
• Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
• Document quality issues and performance measures for management review.
• May liaise with external vendors.
• Analyze and resolve Abbott product customers' technical and clinical questions regarding Abbott products.
• Correspond with customers regarding the results of inquiries and analysis of products.
• Use discretion in escalating unusual product performance issues, collaborate with engineering, resolve customer complaints.
• Participate in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues.
• Interface with all levels of health care professionals (doctors, nurses, biomedical technicians and purchasing agents, materials managers and risk managers) to document, investigate, and correct field-related problems.
• Communicate customer concerns and complaints to individuals who manage databases and analyze data to identify trends, needs for product and service enhancements, and communicate the findings with relevant individuals such as R&D engineers, business unit managers, and other personnel.
• Perform product complaint documentation, investigation, customer response, and consulting activities on Abbott products and author correspondence to customers addressing complaint investigations.
• Serve as a liaison between other business units for quality and technical concerns as needed.

Requirements

• Bachelor’s Degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
• OR an equivalent combination of education and work experience.
• Knowledge of global regulations for medical device reporting and medical terminology is a plus.
• Strong written and oral communication skills are required.
• Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
• Good problem-solving and proficient computer skills are required.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitask, prioritize and meet deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel, including internationally.
• Ability to maintain regular and predictable attendance.

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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.