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
Manufacturing Technician Major Duties and Responsibilities will include, but not be limited to manufacture prototypes, pre-clinical and clinical units. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging. Perform preventive maintenance as required for production equipment[…]
Manufacturing Technician Major Duties and Responsibilities will include, but not be limited to manufacture prototypes, pre-clinical and clinical units. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging. Perform preventive maintenance as required for production equipment[…]
Manager / Director, Research & Development Major Duties and Responsibilities Responsibilities will include, but not be limited to: Identify market opportunities and propose/generate product projects to satisfy these opportunities in line with company goals Establish timing and performance goals for product projects Oversee and/or contribute to R&D project efforts Identify and research new technologies Initiate […]
Manager / Director, Research & Development Major Duties and Responsibilities Responsibilities will include, but not be limited to: Identify market opportunities and propose/generate product projects to satisfy these opportunities in line with company goals Establish timing and performance goals for product projects Oversee and/or contribute to R&D project efforts Identify and research new technologies Initiate […]