Sr Validation Engineer
Join our team and produce products that save and enhance lives!
Shift Hours: Monday-Friday, First Shift; Onsite Full-Time Position.
Position 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 effectively.
MISSION: We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.
New employees are eligible for the following benefits effective date of hire!
Medical, dental, vision benefits, and much more
Company-paid life insurance and disability benefits
401K with company match
17 days of paid time off (pro-rated) and 10 paid Holidays
RESPONSIBILITIES:
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 requirements.
Support regulatory, notified body, and customer inspections, audits, investigations, and inquiries.
Monitor validation activities in accordance with the Validation Master Plan (VMP) and periodic review requirements.
Lead and implement procedural updates concerning the validation program.
Support the completion and maintenance of risk analysis to identify and mitigate potential product quality risks.
Lead the generation and completion of validation protocols and reports for manufacturing equipment/processes, and test and measurement equipment.
Collaborate with Manufacturing Engineers, Supply Chain, and Operations to coordinate validation activities.
Communicate and interact effectively with customers.
Lead or support capability studies and the application of statistical techniques.
Support the preparation of control plans, including inspection, test, and gauge requirements.
Operate with a high level of integrity and initiative, committed to achieving goals and objectives.
Perform other functions as required.
Education
Bachelor’s Degree preferred in Engineering or related field
General understanding of manufacturing equipment/process, software, and test equipment validations.
Experience
Minimum 5+ years' experience as a Validation/Quality Engineer in Medical Device or Regulated Industry.
Skills/Competencies:
Ability to multitask and drive deliverables to completion.
Good communication skills and ability to align with key stakeholders.
Working 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 nature.
Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing.
Manual dexterity sufficient to reach and handle items.
Requires 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.).