The Quality Engineer is 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 control programs in an cGMP and ISO 13485 environment.
- 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.
- Other projects and tasks as assigned.
- 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 Perfect or Word, Mini-Tab, Quattro Pro 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.
- Bachelor of Science degree in Engineering or technical field is desirable with 5+ years of experience. Experience may be considered in lieu of a degree for a candidate who can demonstrate the combination of experience, training and education to be capable of successfully fulfilling all duties and responsibilities of the position.
- Light Work – Exerting up to 20 pounds of force occasionally, and / or up to 10 pounds of force frequently, and / or lift, carry, push, pull or otherwise move objects. If the use of arm and / or leg controls requires exertion of force greater than sedentary work and worker sits most of the time, the job is light work.
- The worker is required to have close visual acuity to perform an activity such as; preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and or operation or machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distance close to the eyes.
- None. The worker is not exposed to adverse environmental conditions (as in typical office or administrative work).
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.