QA Engineer Consultant
Monroeville PA
12 months contract to start with
Description:
Experience: Minimum 8 years professional experience in the applicable role.
Education: Bachelor's /Master's degree in Engineering.
Demonstrated capability and experience in role. Evaluating, investigating, tracking and completing complaints through effective and established complaint handling process. Review designs, documents, records, for compliance to internal procedures and regulations. Ensure proper justification of statistical analysis and hypothesis testing. Participate in device risk management activities, support in establishing proper statistical controls in development and transfer to manufacturing processes, verity data integrity, electronic data storage and data sheet validations. Review and coordinate with Validation for all test method and design validation, review activities related to Design Verification and Design Transfer of Medical Devices, ensure work product meets regulations. Support scientific, complaint, and test failure investigations, Perform data trend analysis, where applicable. Participate in phase reviews, write Quality Procedures, as applicable.
Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com
linkedin.com/in/imranshikalgar