Provide Quality Engineering support for commercial medical device production: Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending and change control support activities. NCR investigation and/or review, including: risk analysis, impact assessment, root cause analysis and material dispositions. Deviation and CAPA process support.
Responsibilities will include, but not be limited to:
•Assist with month-end close (ie: prepare reconciliations, JEs, accruals)
• Post transactions to ledger; reconcile AP transactions; monitor accounts to ensure payments are up to date (ie: AP Aging, Unvouchered Receipts)
•File and process 1099’s annually and ensure W-9’s are up to date
•Understand and maintain the sales/use tax guidelines for accounts payable and purchasing to ensure the accurate payment and recording sales and use tax. Review invoices and statements to ensure that all the information appearing on them is accurate and complete, accrue and adjust as applicable.
• Track and process employee expense reimbursements, and Non-PO invoices in QAD
Author Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documents. Maintain periodic updates, perform gap analysis, and revise existing documents as necessary. Interact with cross-functional teams to collect necessary information to be included in CERs and PMCF documents
ELIXIR MEDICAL STRENGTHENS ITS COMMERCIAL CAPABILITIES WITH THE ADDITION OF AHRAM AS EXECUTIVE VICE PRESIDENT, INTERNATIONAL
MILPITAS, Calif. – March 24, 2022 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced it has appointed Alaeddin Ahram as Executive Vice President, International. Mr. Ahram possesses more than 25 years of leadership experience and successes in building new markets and accelerating commercialization for novel medical devices across Asia, Europe, and […]
ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM
MILPITAS, Calif. – February 15, 2022 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced completion of enrollment in the BIOADAPTOR randomized controlled trial (RCT). The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology, allowing for the restoration of normal […]