Location: Tempe, AZ
Pay: $65,000.00 - $75,000.00 /Year
Name: Lindsey Slazenski
SVS Group, INC. is currently looking to hire an experienced Quality Engineer for one of our best Medical Device Manufacturers in the Tempe area!
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 may be 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 associate 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.
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.