Abbott Compliance Specialist in Caguas, Puerto Rico
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
This is a pipeline requisition for future hiring.
- The Compliance Specialist is responsible to assure that the Corrective Preventive Action System, Quality Audit System; Complaint Handling System complies with company policies and procedures and with FDA and ISO requirements and regulations.Responsible to identify opportunities for quality improvement.
Conduct internal and supplier QS regulation audits to assure compliance with SJM requirements. Conduct failure investigations of manufacturing related issues that may impact quality or reliability of the product and determine any corrective action if require.
Responsible to assure all the compliance audits received in the facility are effectively handled including but not limited to FDA, ISO, and Corporate. Be the liaison with audit room by gathering, reviewing and providing all the required documentation.
Handle all Puerto Rico manufacturing related complaints which include conducting DHR’s review, trending, monitoring, record keeping and assuring investigations are conducted in a timely manner. Be the liaison within the Complaint Handling Units.
Responsible for the CAPA system activities. Implement systems to track and follow-up data sources metrics. Responsible to update the quality metrics by following up and gathering all the require quality information. Prepare management review data including trends, paretos and gap analysis.
Assist and perform investigations of product/regulatory issues by gathering and analyzing information as required.
Work on continuous improvement initiatives to improve our quality system. Must be fully conscious of the QS Regulation and ISO Standards. Provide regulatory training to the facility if require.
Ensure compliance with all procedures and all applicable regulatory agency requirements.
Other duties as assigned.
Bachelor’s degree in Science or Administration is required.
Preferably training in Basic statistics,Quality Auditing, Computer,QSR, ISO13485 and Failure Investigation.
Minimum of four (4) years of work related experience in FDA regulated environment, such as Medical Devices or Pharmaceutical.
Preferably prior experience in quality assurance compliance or lead auditor.
Should have full knowledge and understanding of the standards applicable to the facility (e.g. FDA QS regulation, CFR 820, Medical Device Directive, Canadian Device Regulation, and ISO 13485:.
Must have excellent audit and reporting writing skills including ability to write technical reports.
Fully bilingual (English and Spanish).
Computer knowledge program as Excel, Power Point and Word is a must.
Willing to travel.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com