Responsible for timely and accurate support of investigation processes related to AMO post-market complaints to ensure compliance of all applicable Corporate and divisional policies and procedures.
Demonstrates thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO 13485. Actively participates in departmental process improvements and effectively communicates shared knowledge to contribute to the overall success of AMO. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. This position is primarily responsible for performing investigations related to AMO product returns associated with complaints. The position interacts with US and non-US AMO divisions, third party vendors and AMO customers. Primary duties include: 1. Coordinate product return receiving and processing 2. Performing and documenting returned product testing in accordance with established procedures 3. Accurate and timely data entry and correspondence related to AMO product complaints 4. Demonstrate familiarity with GMP, FDA and ISO13485 requirements 5. Ability to move boxes, pack and unpack products for storage and/or shipping. 6. Decontamination of returned complaint product when necessary. The position is accountable for timely processing of returned product. Candidate will be responsible for maintaining effective relationship with AMO manufacturers and vendors, and communicating sensitive and confidential information that require tact and sound judgment. This position requires a self-starter that is detail and results oriented. Must be able to read, write and speak English well to be able to communicate via email and phone. Any foreign language skills are a plus. Any experience processing complaints or returned goods is helpful. Minimum of two years working in an FDA regulated medical device industry is preferable. Person must be computer literate and competent in Windows, Microsoft Office (Word, Excel). Prior experience using complaints processing software (such as CATSWeb) is desirable. Mechanical and optical inspection experience is preferred.