
Quality Engineer III
- Maple Grove, MN
- $76,000 per year
- Permanent
- Full-time
- Lead or participate in projects to identify root cause and implement corrective and preventive actions.
- Responsible for understanding nonconformance scope, implementing product/process controls, and determining release criteria. Responsible for investigating nonconformances and writing required documentation.
- Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design.
- Perform process validation and verification activities and review related documentation
- Support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Develop and update risk management deliverables
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
- Bachelors of Science in Engineering or Science Related field
- Minimum of 3 years of relevant experience, specifically working with Process Validation and Verification activities and risk management documentation such as Design/Process FMEAs
- Experience in medical device field in a manufacturing support role a plus
- Experience in quality line support
- Good written and verbal communication skills.
- Must be able to work independently under limited supervision
- Knowledge of basic Quality Systems and good documentation practices
- Self-starter with the ability to identify improvement opportunities
- Experience leading cross-functional teams and driving projects to completion.
- Demonstrated experience managing multiple projects covering diverse engineering (i.e. equipment qualification, process validation, test method validation) disciplines.
- Prior interactions with the following disciplines: manufacturing engineering, CAPA, risk management, supplier quality, and process engineering
- Knowledge of analytical techniques, problem solving and statistical analysis
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
- Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System