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Senior Specialist, Product Surveillance

3 months ago

Burlington, United States Abbott Laboratories Full time

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

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. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • 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 bachelorâs 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 Burlington, MA location in the Heart Failure division.

In Abbottâs Heart Failure (HF) business, weâre developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Senior Specialist, Product Surveillance will be responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. An individual contributor with comprehensive knowledge in the specific area. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions.

What Youâll Work On

  • Under general direction, has duties of instructing, directing, and checking the work of other quality assurance professionals.

  • Applies clinical knowledge and experience to guide and augment appropriateness of clinical events that impact reportability.

  • Applies clinical knowledge and experience to support staff as clinical resource.

  • Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for 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.

  • Travel up to 10% of the time both domestically and internationally by any means necessary for initial product training and to support organizational goals *****CMEMS position.

  • Drives functional performance that ensures cross-functional standards and expectations are met.

EDUCATION AND EXPERIENCE YOUâLL BRING

  • Bachelors Degree Related field an equivalent combination of education and work experience

  • Masters Degree Preferred

  • Minimum 6 years

  • Related work experience with a strong understanding of specified functional area. Solid understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit.

Preferred Qualifications:

  • Registered Nurse (RN)

  • Experience: Minimum 4 years â In related clinical discipline, Registered Nurse (RN)

  • Critical care and or cardiac care background.

  • Heart Failure background

  • Device experience: i.e. LVAD, Cmag, CMEMs

  • Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.

  • Ability to work independently and in groups; ability to work cross-functionally.  Demonstrated initiative and problem-solving skills and critical-thinking skills.

  • Ability and aptitude to use various types of databases and other computer software. Ability to prioritize.

  • Strong organizational and project management skills. Ability or aptitude to lead without direct authority.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.



The base pay for this position is $72,700.00 â $145,300.00. In specific locations, the pay range may vary from the range posted.