Senior Product Support Specialist

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.

JOB DESCRIPTION:

Senior Product Support Specialist

Charlottesville, VA

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're 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 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 of your dreams.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 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 the best place to work for diverse, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Charlottesville, VA location in the Cardiometabolic and Informatics. Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

As the Senior Product Support Specialist, you'll have the chance to

What You'll Work On

• Participate in, or lead, the completion of Nonconformance events (QI/CAPA/FCA), assuring compliance, quality, and timeliness of records.
• Provide support and subject matter expertise during audits and inspections.
• Lead meetings and communications for QI/CAPA updates, information, and concerns.
• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
• Work across multiple sites and participate in business wide activities to accomplish quality system objectives.
• Assist with creating/publishing metrics and reporting on regular basis in accordance with established procedures.
• Contribute to continuous improvement initiatives and projects.
• Interact and build relationships with multiple teams within ARDx Informatics and within the larger business unit.
• Initiate and oversee the processing and completion of Nonconformance records in the electronic system, which will include processing requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.

Required Qualifications

• BS degree or mix of education and relevant experience.
• Previous QI/CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong organizational and follow-up skills, as well as attention to detail.
• Demonstrated project management skills, including the ability to resolve quality-related issues in a timely and effective manner.

Preferred Qualifications

• Prior Software As a Medical Device (SaMD) experience.
• ASQ CQT, CQE, CQA certification.
• Six Sigma root cause analysis/problem solving training and experience.
• Solid interpersonal skills, with the ability to leverage and/or engage others to accomplish goals and objectives.
• The ability to communicate confidently and effectively with multiple levels in an organization.

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 and @AbbottGlobal.

The salary for this role is between:

N/A

JOB FAMILY:

Operations Quality

DIVISION:

CMI ARDx Cardiometabolic and Informatics

LOCATION:

United States > Charlottesville : 2000 Holiday Drive

ADDITIONAL LOCATIONS:

United States of America : Remote

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

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