JOB DESCRIPTION:
Senior Compliance Specialist 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 in Arecibo, Puerto Rico for our Cardiac Rhythm Management Division. 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 Compliance Specialist is responsible to lead readiness activities and compliance programs to maintain and strengthening the Quality System so Abbott can meet the standard. Also supervise the CAPA and manufacturing investigators ensuring the investigations complies with the Abbott policies, procedures.
What You’ll Do
Supervise manufacturing investigators and CAPA Analyst providing mentorship, tracking and development supporting the attainment of Division goals and objectives.
Administer, track, and maintain the internal readiness efforts and programs to ensure compliance of the site with the applicable regulation, standards, and policies.
Responsible to assure all the compliance audits received in the facility are effectively handled including, but not limited to: FDA, ISO, AQR and internal audits.
Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for non-conformances, potential non-conformances, CAPAs, deviations, and/or manufacturing investigations.
Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
Perform and report line defects trend analysis, cost of quality and period quality summaries.
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.
Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.
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.
Other duties as assigned.
Required Qualifications
Bachelor's degree.
Minimum 5 years of experience, both overall and any industry-specific experience needed.
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.
Other requirements:
Preferred knowledge in programming with Python and HTML; and Designing Drawings with AutoCAD
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
$66,000.00 – $132,000.00In 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.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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What We Do
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 109,000 colleagues serve people in more than 160 countries.
