Job Description

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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

Abbott Rapid Diagnostics is part of Abbotts Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Quality Engineer IV is within our Cardiometabolic business unit located in San Diego, California. This role is responsible for quality engineering activities, to monitor and measure Abbott compliance with the Quality System Regulation, Abbott Quality policies, FDA and ISO regulations as well as Abbott product quality and compliance objectives.

RESPONSIBILITIES:

* Lead Risk Management activities using the Failure Mode and Effect Analysis methodology (e.g. sFMEA, dFMEA, pFMEA).
* Lead the development of mitigations for failure modes and verify the effectiveness of these mitigations.
* Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
* Lead NC and CAPA activities such as risk assessments, root cause investigations, and action plans.
* Provide resolution of quality issues identified by production and project teams in accordance with established procedures.
* Lead Quality requirements within the design transfer, design control and improvement project teams.
* Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.
* Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
* Other duties as assigned, according to the changing needs of the business.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

B.S. degree; with a minimum of 6-8 years of related experience in Quality Engineering.

PREFERRED QUALIFICATIONS:

* Experience with root cause analysis, design control, design transfer, Risk Management, and validation activities.
* ASQ Certified Quality Engineer certification.
* Analytical/Problem Solving Skills (e.g. DMAIC, statistical, risk analysis, engineering analysis)
* Writing and Communication Skills (e.g. write technical reports, present data analysis)
* Interpersonal Skills
* Service Orientation
* Working knowledge of FDAs 21 CFR Part 820 Quality System Regulation, ISO 13485:2016 Medical Devices, and ISO 14971:2012 Risk Management

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

JOB FAMILY:

Engineering

DIVISION:

ARDx Abbott Rapid Diagnostics

LOCATION:

United States of America : Remote

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)

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