Viant, a leading manufacturer of medical devices, is looking for a Quality Engineer to join their Westfield, PA team. This is a critical role responsible for all aspects of quality assurance including first article inspections, capability studies, DOE, developing procedures, root cause analysis, corrective and preventative actions and all other areas of quality assurance programs in a cGMP and ISO 13485 environment.
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
- 72,000 sq. ft
- Class 7 and 8 clean rooms
- 63 molding presses (55 tons – 385 tons)
- ISO 13485 certified, ISO 9001
- Molding: multicomponent, over, insert, two-shot
- Product assembly and packaging
- Dedicated automation cells
- Specializing in round, clear, high-volume parts
- Bachelor of Science degree in Engineering or technical field is desirable with 5+ years of experience.
- Knowledge and familiarity with OGP (Optical Gauging Product) CMM (Coordinate Measuring Machine) and other measuring devices used to ensure quality and acceptability of the product.
- Requires the ability to read and interpret blueprints.
- Familiarity with GDT (Geometric Dimension & Tolerance) procedures and requirements.
- Perform various computer related tasks and programs including but not limited to: Excel, Microsoft Access, Word, Mini-Tab, and/or others related to the Quality Department very desirable.
- Strong organizational skills with proven ability to complete multiple tasks simultaneously.
- Working knowledge of ISO 13485, SPC, Six Sigma, Excel, Minitab, and Team Building a plus.
- Previous experience in gage selection, use and maintenance and in automated gage SPC systems and the ability to Apply GD&T (Geometric Dimension & Tolerance) where applicable.
- Five years’ experience in plastic industry a plus.
Please click Apply or email your information to: email@example.com
- Support New Product Development. Develop and execute process validation protocols and publish reports. Develop area, process and supplier quality plans and out of control action plans. Implement Statistical Process Control in manufacturing processes where applicable.
- Provide training as needed on new procedures being enforced. Support Inspection Function, training employees engaged in inspection and testing activities to ensure compliance to procedures and policies.
- Participate in review of manufacturing and testing of new products to assure quality requirements are fulfilled. Implementation and continuous improvement of testing procedures and SPC programs.
- Assures compliance to in-house and external specifications and standards, such as GMP s and ISO regulations.
- Interface with customers, vendors, and 3rd party assessors, as needed.
- Ensure proper usage and calibration of measuring devices, i.e. calipers, micrometers, etc.
- Assist in programs for maintaining sanitation, good manufacturing practice, and food safety programs and inspections.
- Tracks all nonconformance reports all MRB and part issues.
- Assist in team problem solving with statistical data and backup information as necessary.
- Coordinate special projects for the QA Department as necessary.
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.