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.

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Our location in Sylmar, CA currently has an opportunity for a Postmarket Surveillance Analyst role.   As a Postmarket Surveillance Analyst you will analyze quality standards for components, materials or services.

Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.

WHAT YOU’LL DO

• 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.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree (± 16 years). 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

Experience/Background

• 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.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal.

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.

• quality analysis
• complaint investigation
• medical device reporting
• regulatory compliance
• product inspection
• data analysis
• report preparation
• customer communication
• stakeholder management
• computer proficiency
• attention to detail
• multitasking
• follow-up skills