Sr Validation Engineer

Join our team and produce products that save and enhance lives!Shift Hours: Monday-Friday First Shift; Onsite Full-Time Summary: The primary purpose of this job is to provide Validation/Quality Engineering support for operations to ensure Quality System and Medical Device Regulatory requirements are adhered to. This is an independent contributor role that requires the ability to work autonomously and manage multiple tasks :We partner and innovate with our customers to provide the highest quality life enhancing medical devices in the employees are eligible for the following benefits effective date of hire!Medical dental vision benefits and much moreCompany-paid life insurance and disability benefits401K with company match 17 days of paid time off (pro-rated) and 10 paid HolidaysRESPONSIBILITIES:Adheres to Viant Core Beliefs and all safety and quality requirements including but not limited to: Quality Management Systems (QMS) Environmental Management Systems (EMS) U.S. Food and Drug Administration (FDA) Regulations Company policies and operating procedures and other regulatory requirements. Lead the Validation Program for the Viant Medical Indianapolis Manufacturing Site ensuring compliance with regulatory notified body and customer regulatory notified body and customer inspections audits investigations and validation activities in accordance with the Validation Master Plan (VMP) and periodic review and implement procedural updates concerning the validation the completion and maintenance of risk analysis to identify and mitigate potential product quality the generation and completion of validation protocols and reports for manufacturing equipment/processes and test and measurement with Manufacturing Engineers Supply Chain and Operations to coordinate validation and interact effectively with or support capability studies and the application of statistical the preparation of control plans including inspection test and gauge with a high level of integrity and initiative committed to achieving goals and other functions as Bachelors Degree preferred in Engineering or related fieldGeneral understanding of manufacturing equipment/process software and test equipment Minimum 5 years experience as a Validation/Quality Engineer in Medical Device or Regulated to multitask and drive deliverables to communication skills and ability to align with key knowledge in the interpretation and application of relevant Regulations and Industry Standards (e.g. FDA 21CFR820/QMSR ISO13485 ISO14971).Physical:Light physical activity performing non-strenuous day-to-day activities of an administrative lifting (20 lbs.) carrying (10 lbs.) bending pushing/pulling crawling climbing balancing and prolonged dexterity sufficient to reach and handle the ability to identify and distinguish colors judge distance and space relationships (i.e. visualize objects of multiple dimensions) and adjust the lens of the eye to bring an object into sharp focus (microscope etc.).