Quality Associate I

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Responsible for insuring compliance with the Quality System Regulation regarding quality and manufacturing processes and methods.
• Revise and approve all documentation related to the areas of responsibilities such as: In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others.
• Perform routine audits of sampling techniques testing skills and all documentation performed by the TIQ's.
• Provide training as required on: Good Documentation Practices, SPC, Total Integrated Quality and others sed.
• Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.
• Assist in the development / certification of the TIQ’s.
• Responsible for conducting EHS inspections to identify and correct safety hazards and environmental aspects.
• Follow the EHS applicable procedures, and analyze EHS incidents (including near misses) to find causes and take corrective action.

Qualifications:

•  Bachelor degree in Science
• Two (2) years of previous experience in the related job on Medical Device Industry
• Bilingual (English & Spanish).
• Knowledge in Data Entry – Microsoft Office Software.
• Basic computer knowledge is required
• Experience in measurements instrumentation. 
• Must be able to work 3rd shift