Compliance Specialist - Arecibo

Descripción del Empleo:
Spectraforce Technologies is a leader of Staffing Services for companies worldwide. We are looking for a Compliance Specialist for Arecibo, PR. 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.
Requisitos:
Requirements: 4 years experience required in related experience in FDA regulated environment in the Pharmaceutical or Medical Devices Industry.
Prior experience in quality assurance compliance or lead auditor preferred.
Education: Bachelor degree in Business Administration/ Science or equivalent experience.

Skills:
Must possess excellent organizational and communication skills both verbal and written in Spanish and English.
Knowledge of FDA QS regulation, CFR 820, Medical Device Directive, Canadian Device Regulation, and ISO 13485.
Excellent audit and reporting writing skills including ability to write technical reports.
Demonstrated capabilities with the use of PC and MS Office applications such as Excel and Word.