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).

　　Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate. 

　　Able to Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

　　Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned. 

　　Must be able to work 3rd shift.

　　Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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