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:
Senior Quality Engineer for Cardiac Rhythm Management, this position is based in Arecibo, Puerto Rico.
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
This position is based inArecibo,Puerto Ricofor ourCardiac Rhythm ManagementDivision. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
As the Senior 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. This position will have responsibility for quality compliance for all products produced in the Abbott-CRM facility. This position works 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.
WhatYou’llDo
Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action. (Weight=20%)
Perform or assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions. Recommend corrective actions. (Weight=15%)
Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product – assist in process validation protocol. (Weight=10%)
Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends. (Weight=5%)
Perform and report line defects trend analysis, cost of quality and period quality summaries. (Weight=10%)
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. (Weight=10%)
Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement. (Weight=10%)
May have supervisory responsibility over Quality Technicians, Quality Engineers, receiving and in-process inspection (QC) personnel. (Weight=5%)
Ensure compliance with all Abbott procedures and all applicable regulatory agency requirements. (Weight=10%)
Other duties as assigned. (Weight=5%)
RequiredQualifications
Bachelor's degree in engineering required.
Advanced degree or process towards advanced degree is a desirable. Credentials of a Certified Quality Engineer are desirable.
Minimum 6 years in a similar position in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.
Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.
Knowledge in DOE, Six Sigma and product transfer is a desirable.
Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP and, auditing principals.
Prior experience auditing FDA regulations preferred.
Bilingual proficiency in English and Spanish, with strong conversational, written, and reading skills.
Strong communication and analytical skills, with the ability to manage multiple priorities and deliver high-quality results in time sensitive environments.
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.
The base pay for this position is
$66,000.00 – $132,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
Puerto Rico > Arecibo : Santana Industrial Park Interior Lot A, Road #2, Km 67.5
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
