Sturtevant, Wisconsin | September 25, 2019
In this role at our Qure – Medical Sturtevant site, you will provide analysis and systems development to ensure products are manufactured to meet or exceed Customer requirements and expectations and works to improve quality for the product while identifying and eliminating waste.
- Develop and initiate standards and methods for inspection and testing.
- Conduct 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.
- Develop quality plans from customer specifications to meet customer, company and QMS requirements.
- Perform and analyzes capability studies, gage r&r, and First Article Inspection Reports on both new and existing products.
- Facilitate improvements to the Quality Management System via updates to procedures and Work Instructions stemming from audit findings and continuous improvement initiatives.
- Work with engineering to coordinate and prepare sample submission packages; updates and maintains process flow diagrams and process control plans.
- Work with Operations on lean and scrap reduction initiatives
- Work with Engineering and Operations to solve in-house quality concerns, reviews of nonconforming product, recommends disposition and corrective action to prevent re occurrence.
- Creates and maintains company quality documentation, such as quality procedures, work instructions and forms.
- 4 year degree in Quality, Engineering, Statistics or technical field
- Experience in Quality Assurance in an ISO or FDA registered manufacturing environment.
- Must have strong working knowledge of Statistical Process Control methods using intermediate and advanced statistics. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- CQE or CQA preferred
- Six Sigma Green Belt certification preferred
- Sound knowledge of ISO 21CFR820 and/or ISO 13485 quality systems preferred.