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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Postmarket Surveillance Analyst I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to: 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 bachelors 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. The Opportunity This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbotts Electrophysiology (EP) business, were advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Postmarket Surveillance Analyst I, you'll perform evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; coordinating product testing/analysis with other Abbott departments and external consultants; preparing technical reports of evaluation findings; and operating and maintaining the Postmarket Surveillance Laboratory equipment. What Youll Work On Performs product evaluations in a timely manner to develop a well-documented and accurate root cause evaluation Uses procedures, judgement and experience to determine appropriate testing of returned products with minimal guidance Reviews all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations) Ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues) and coordinate product evaluations with other Abbott departments and external consultants when needed Interprets/reviews technical product specifications, measurements, and the Device History Record Prepares technical reports of findings and enters them into the complaint system; maintains accurate entry of complaints in the database Maintains work area in clean and orderly condition and adheres to safety and biohazard procedures Independently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings Adheres to the device retention and disposal procedures Is diligent of any unusual trends in product complaints and communicates them to management Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings) Ensures accurate department procedures and work instructions are maintained Train new employees to the complaint handling process Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 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, on occasion, as assigned Required Qualifications Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work 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 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 Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Multitasks, prioritizes and meets deadlines in timely manner Strong organizational and follow-up skills, as well as attention to detail Ability to travel approximately 10%, including internationally Ability to maintain regular and predictable attendance Preferred Qualifications Knowledge of global regulations for medical device reporting and medical terminology is a plus Experience working in a broader enterprise/cross-division business unit model preferred. Apply Now 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. 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 $50,000.00 $100,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter