Senior Specialist Quality Assurance

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. WhatYou’llDo

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.

RequiredQualifications

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