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Abbott

Senior Specialist Product Performance

Posted 12 Days Ago
Be an Early Applicant
Burlington, MA
75K-151K Annually
Mid level
Burlington, MA
75K-151K Annually
Mid level
The Senior Specialist Product Performance oversees quality assurance in the Heart Failure division, ensuring compliance with regulations and improving product quality through clinical expertise and teamwork.
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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:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Burlington, MA location in Abbot’s Heart Failure division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

This position of SENIOR SPECIALIST, PRODUCT PERFORMANCE works within our Quality Team supporting all parts of Abbott Heart Failure. This role has responsibility for complaint handling and is process owner for clinical and regulatory decision making. This role will be the subject matter expert, work closely with Commercial, Operations, and Design teams, and interact with regulatory agencies and customers to ensure the division follows global complaint handling procedures and regulations.

What You’ll Do

  • 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 regulatory 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

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

  • 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.

  • 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.

Required Qualifications:

  • Education Level: Bachelors Degree  in a related field Nursing, Pre-Med, Engineering, Life Sciences (+16 years)

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

Preferred Qualifications:

  • Registered Nurse (RN)

  • Critical care and or cardiac care background.

  • Heart Failure background

  • Device experience: i.e. LVAD, Heartmate, Centrimag, CardioMEMs

  • 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

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

$75,300.00 – $150,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:Operations Quality

     

DIVISION:HF Heart Failure

        

LOCATION:United States > Massachusetts > Burlington : 168 Middlesex Turnpike

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Yes, 5 % of the Time

     

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

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