Permanent position: This Quality Engineer position is with a growing medical device company located in Sturtevant Wisconsin. This person will be a hands on individual that provides analysis and systems development to ensure products are manufactured to meet or exceed customer requirements and expectations. The Quality Engineer will work to improve quality for the product while identifying and eliminating waste. Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Develops and initiates standards and methods for inspection and testing.
- Conducts root cause analysis, analyze failures and implement corrective action for process / product related concerns and customer complaints.
- Interfaces with customer to resolve complaints, corrective actions, engineering changes and validation requirements.
- Develops quality plans from customer specifications to meet customer, company and QMS requirements.
- Performs and analyzes capability studies, gauge r&r and First Article Inspection Reports on both new and existing products.
- Facilitates improvements to the Quality Management System via updates to procedures and work instructions stemming from audit findings and continuous improvement initiatives.
- Works with operations on lean and scrap reduction initiatives.
- 4 year degree in Quality, Engineering, Statistics or technical field.
- Experience in quality assurance in a ISO or FDA registered manufacturing environment.
- Must have strong working knowledge of statistical process control methods.
- Sound knowledge of ISO 13485 quality systems preferred.
- Competitive benefits package and 15% bonus program
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.