Viant, a leading manufacturer of medical devices, is looking for a Quality Engineer to join their Elkhorn, WI team. This is a critical role responsible for providing quality assurance knowledge and hands on support to operations to ensure that the quality system requirements are adhered to for medical device manufacturing according to but not limited ISO 13485 and FDA 820 standards.
Some of the benefits to you:
- Competitive compensation
- Benefits package (starting day 1) that includes: medical, dental, vision and 401(k) with company match (401k after 90 days)
- Paid time off and holidays
- Greater stability – Viant recently doubled in size and is investing heavily in their facilities
- Bachelor of Science degree in Engineering, Biology or technical field with a minimum of 3 years of experience (Additional experience may be considered in lieu of a degree)
- Experience in fast paced contract manufacturing and/or manufacturing environment required
- Experience working in a regulated environment with specific knowledge of FDA QSR and ISO 13485 standards
- Experience in medical device manufacturing
- Knowledge and familiarity with optical gauging product (OGP), coordinate measuring machine (CMM), other mechanical measurement equipment (indicators, micrometers, etc.), and other measuring devices used to ensure quality and acceptability of product
- Knowledge of statistical techniques (design of experiments, measurement R&R, statistical process control)
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- Providing quality representation, support and improvements to Viant’s quality systems
- Quality assurance testing methodology, complaint investigation and resolution, root cause analysis, corrective and preventive actions
- Validations including but not limited to capability studies and first article inspections, internal/external audits, training initiatives, process improvement activities, and other business initiatives required quality support
- 45,000 sq. ft.
- Class 7 clean room, white room.
- 40 molding presses (28 tons – 500 tons)
- ISO 13485 certified, ISO 9001
- Thermoset elastomer molding, including LSR, LIM
- Injection, compression, and transfer molding
- Blow/fill/seal with injectable water
- Custom material formulating/mixing
- Dedicated automation cells
About the company: With over 35 years of medical device molding experience, Viant has become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.
All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.