Quality and Regulatory Compliance Analyst

Job description

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.

JOB DESCRIPTION:

Essential Functions

• Provide support to business units under your responsibility to ensure compliance with Quality policies and procedures, as well local regulations.
• Elaboration, change, review, as well approve documents related to Quality Management System, according to company´s policies and regulatory requirements.
• Obtain and renewal Quality System Certifications.
• Provide data for Management Review Meetings for the affiliate.
• Recognize a non-conformance or potential non-conformance, and collaborate with impacted areas to conduct corrective and preventive actions according to company´s procedures and systems.
• Evaluate received products and provide a disposition according to company´s procedures.
• Ensure non-conforming products are segregated in a way to prevent distribution, including those related to Stop Shipment/Quality Hold/Ship Hold/FCA/FSCA.
• Coordinate local activities related to Field Action, including report to Competent Authorities in the country.
• Execute activities related to Product Experience Reporting, including report to manufacturer, return of products to analysis, follow-up on questions received, and report to Competent Authorities.
• Monitor and evaluate service/logistic complaints, in order to ensure if any impact to qualify or customer was identified and proper actions are performed.
• Provide support on customer surveys, evaluating results and identifying the need of any action related to quality.
• Perform Supplier and Distributor Qualification according to company´s procedures.
• Maintain quality records and databases according to company´s procedures.
• Ensure that affiliate comply with local regulation and informed regarding any important topic (Emerging Issues) related to Quality that could potentially impact the business, providing must accurate and updated information to Manufacturer.
• Conduct internal and external audits, according to company´s procedures.
• Conduct trainings related to Quality and Regulatory Compliance.
• Compile local Quality and Regulatory Compliance metrics and report to management.
• Ensure warehouse where products are storage, complies with good storage and distribution practices.
• Comply with policies and procedures established for the company.
• Conduct actions and decisions of responsibility of this position according to company´s Code of Conduct.
• Conduct activities according to EHS (Environment, Health and Safety) policies and practices.

Education Requirements

• Bachelor’s Degree in Health Sciences area.

Experience Requirement

• Minimum of 2 years of related experience
• Preferred experience in Quality System for Medical Devices.
• Experience in ISO 13485 +1 years

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