Quality Engineer II, Product
$82,862–$111,864 year
On-siteBrooklyn Park, Minnesota, United States
Job Summary
Assist in the design and execution of Production Release Process projects for components and finished devices while leading complex quality improvement initiatives. Demonstrate project management skills by collaborating with cross-functional teams to achieve objectives and lead Process and Design Risk Analysis activities to identify and mitigate potential risks. Provide leadership regarding quality regulations and compliance requirements, supporting Design Control and Process Validation activities for new product development. Lead the implementation of cost of quality initiatives through data collection, analysis, and reporting. Support Manufacturing Engineering in creating and maintaining Device Master Records, Device History Records, manufacturing routes, bills of materials, and product specifications. Ensure compliance with all applicable laws, regulations, and policies relevant to the role.
Required Qualifications
- Bachelor's Degree in Engineering
- Minimum of 2-4 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment
- Proficient with Six Sigma type tools to analyse, drive root cause, and solve problems
- Knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab
- Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, & ISO 11135
- Proficient and have practical knowledge in Microsoft Word, Excel, and PowerPoint
- Must be able to work well within a team and independently at times with limited guidance
- Strong written and oral communication skills
- Ability to thrive in a fast-paced, dynamic and deadline-driven environment
- Self-motivated with the ability to prioritize/execute multiple concurrent tasks
- Skilled in presentation development and public speaking
- General curiosity and a desire to learn new material
- Up to 10% domestic travel
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