Direct Hire position!
- Use analytical methods to trend data from the Quality Management System, perform capability studies, Gage R & R studies, create control plans, FMEA, DOE and other quality documentation requested by customer's and/or required for internal use.
- Working with relevant engineering, business development managers and production associates to develop inspection and test methods, equipment qualifications and process validation protocols.
- Assist Quality team associates in the creation of receiving inspection instructions.
- Represent Quality team in project meetings and completing assigned tasks on time.
- Identify and implement inspection methods and equipment to reduce cost and improve productivity.
- Accountable for analyzing data, establishing methods and implementing process changes to reduce the frequency of non-conformances.
- Create, analyze and drive corrective actions to completion.
- Four year Bachelor of Science/Engineering degree
- 2-3 years of medical manufacturing experience
- Experience in an automated manufacturing and testing environment. Rotary converting a plus.
- ASQ Certified Quality Engineering certificate preferred.
- Proficient PC skills in Mini-Tab and Microsoft Office. Experience using CAD software a plus.
- Experience in a fast paced custom development and manufacturing environment.
- Excellent communication skills, both written and verbal.
- Strong math skills with ability to understand descriptive and inferential statistics.
- Ability to read blueprints, recognize UL specifications and understand geometric dimensioning and tolerances.
- Demonstrates an understanding of ISO 13485 and GMP requirements through active participation in training programs and using the information as guidelines in technical writing to insure ongoing compliance.
- Ability to understand material characteristics, tooling specifications, equipment, and how materials, tooling, and process settings interact to affect the overall tolerance capability of various product designs.
- Ability to balance the requirement for meeting customer expectations and FDA regulations with company profitability in supporting the Quality Technician in developing estimates for work and inspection instructions.
- Excellent attention to detail.
- Demonstrated application of Six Sigma manufacturing concepts and Lean concepts.
- Ability to determine appropriate inspection tools to be used i.e. fixtures, templates, coordinate measuring machine, and go-no go gauges, etc.
- Ability to create and sustain effective relationships both internally and externally.