Associate Failure Analysis Engineer (On-site)

Job description

Job Title: Associate Failure Analysis Engineer Department: 8610 – QA Post Market Quality Assurance FLSA Status: Non-Exempt: Position Overview: The Associate Failure Analysis Engineer plays an integral role in Insulet’s Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals. Responsibilities: - Perform moderately complex tasks to ensure compliance with quality standards. - Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained. - Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA. - Perform product testing and failure analysis. - Review Lot Acceptance records and DHRs, create trend charts. - Perform investigation triage and deep dive investigations to develop hypothesis for failure. - Collect log quality data and trend results. - Accountability for quality investigation and root cause...