Experience in the medical device industry Only (Baxter Health Care or Abbott Labs) , with exposure to quality and manufacturing processes. Has an in-depth understanding of quality management systems, manufacturing processes, and materials.
Minimum of five years of medical device industry experience with strong working knowledge of quality audits, both internal and supplier, 21 CFR 820, part 803, part 806, part 11; ISO 13485; GMPs; and other applicable international standards.
Strong analytical, written, and verbal communication skills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.
Advanced computer software skills with word processing, database management, and data analysis. Knowledge of contemporary statistical analysis package(s) is preferred.
ASQ Certification (CQA, CQE) or equivalent quality auditing experience is desired.
Excellent verbal communication and presentation skills appropriate for acting as a liaison between company and its suppliers. Must be comfortable making accurate assessments and decisions with limited time during an audit. Must be able to determine important data to obtain and resolve barriers to obtaining it.
Worked on Batch Release system interfaced with TRACKWISE application
Able to create test cases on HPQC and mapped the requirements for Trace Matrix (URS>FS>Test Cases)
Develop, maintain and execute validation test scripts, test metrics and generated reports for management use in determining project and applications test status and coordinated testing schedule with IT team.
Document several Problem Reports and Incident Reports for the tickets created through Global Help Desk for ARISg production bugs.