Science & Biotech - Boston, MA 02184     (Created on Oct 07, 2009)

Tags: Quality Assurance, Compliance, medical products, Complaints, Managment,cGMP manufacturing

Responsible for compliance of facilities to requirements of FDA (21 CRF 820), applicable international regulations (MDD 93/42/EEC, CMDR), and standards (ISO13485), including: Manages global Blood Management Solutions customer complaint compliance including 1) PIR documentation, investigation & response; 2) Device defects investigation and response; 3) Services issues investigation and support; 4)Analysis of complaint trends and determination of corrective actions; and 5) Determination and notification of MDR/ADE (vigilance) events. Liaison between QS, Manufacturing, and R&D providing data analysis for global quality issues. Participates as a member of internal audit programs and Quality Systems controls. Provides management reports on effectiveness on CAPA, complaint, and product launch surveillance processes.

Education: Bachelors degree required. 5 years of experience in Quality Assurance and Compliance for the design and production of medical products required. Exp. In operating successfully within an FDA regulated cGMP manufacturing facility is mandatory. Travel- 10-15% of the time-International Travel specifically Asia and Japan.

Compensation: 135,000 with a 10-20% Bonus

Tags: Quality Assurance, Compliance, medical products, Complaints, Managment,cGMP manufacturing


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