Postmarket Surveillance Analyst I

What You’ll Work On

• Apply quality principles, analyzes quality records, prepares reports and recommends 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.

• Analyzes and resolves Abbott product customers technical and clinical questions regarding Abbott products.

• Corresponds with customers regarding the results of inquiries and analysis of products.

• Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer complaints. Participates in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues.

• This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints. Interfaces 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.

• Communicates 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 to communicate the findings.

• Performs product complaint documentation, investigation, customer response, and consulting activities on Abbott products and authors correspondence to customers addressing complaint investigations.

• Serves as a liaison between other business units for quality and technical concerns as needed.

Required Qualifications

• Bachelors 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. Candidate must be able 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.

• Multitasks, prioritizes and meets deadlines in 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(if required only).

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.

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