Quality Engineer

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:

Job Description

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 family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.
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
As a

Quality Engineer

you will

ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing non-conformances, complaints, defect reports, and audit findings in order to coordinate corrective action. Will have responsibility for quality compliance for all products produced in the facility. Will work with minimum supervision and has appreciable latitude for implementing actions. Assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.
This position works in our

Structural Heart manufacturing business

in

Caguas, Puerto Rico at the first shift Monday to Friday will support Quality Operations.
What You'll Do
Maintain inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges.
Participate in continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement. Perform qualifications assigned.
Perform and report line defects trend analysis, cost of quality, and period quality summaries.
Participate in the development, delivery, and administration of quality training programs including GMP and contamination control.
Perform or review manufacturing non conformances reports, customer complaints, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action. Participate in regulatory agencies audits.
Perform quality system audits in order to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor. Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.
Perform or assist in the investigation of product non conformances and gathering of information during regulatory inspections and field actions.
Ensure compliance with all procedures and all applicable regulatory agency requirements.
Other duties as assigned.
Required Qualifications
Bachelor's degree in engineering is required.
2+ years of prior experience in manufacturing, quality control, quality assurance, or regulatory compliance is required.
Prior experience in medical device or pharmaceutical manufacturing is preferred.
Must have fundamental knowledge of concepts, practices, and procedures of a particular field of

specialization.
Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.
Project Management is desirable.
Knowledge in DOE, Six Sigma and product transfer is a plus.
Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
Risk Management knowledge.
Knowledge in CAPA, Nonconformance Technical Writing, Process & Software Validation, MES System.
Must be bilingual (English and Spanish), possess good communication and analytical skills, and ability to work under deadlines.
Apply Now
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
$53,300.00 – $106,700.00

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

Operations Quality

DIVISION:

SH Structural Heart

LOCATION:

Puerto Rico > Caguas : West Industrial Park Calle B, Lote #20

ADDITIONAL LOCATIONS:

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), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time 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 it’s 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 life’s 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.

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