Quality Engineer I

About This Role

Support manufacturing operations for medical device production, focusing on process optimization, troubleshooting, and ensuring production goals are met. Apply engineering analysis for investigations and implement process control systems for product development and ongoing manufacturing.

Responsibilities

• Support manufacturing operations by monitoring equipment performance, troubleshooting process issues, and optimizing production workflows
• Conduct engineering analysis for yield fallout investigations, process monitoring, manufacturing instruction compliance, and corrective/preventive actions (CAPA)
• Identify and implement process control systems to support product development, qualification, and ongoing manufacturing
• Work with vendors/suppliers to design and procure tooling, fixtures, and equipment
• Train and provide technical support to product builders, technicians, and peers
• Lead and contribute to Value Improvement (VIP), DMAIC, or other process improvement projects with cross-functional teams
• Collect and analyze data using statistical methods for process characterization, Cpk, and scrap reduction goals
• Participate in new product development teams, including technology development, material/product testing, preparation of specifications, and process improvements
• Coordinate, manage, and document project goals and progress, recommending adjustments as needed
• Serve as a quality representative to communicate initiatives, support decisions, and improve awareness of quality practices

Requirements

• Minimum of a Bachelor’s Degree in Engineering (Mechanical, Chemical, or related discipline)
• Minimum of less than one year of experience
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Chemical, or related discipline)
• Less than one year of experience

Nice to Have

• Experience in medical device or highly regulated manufacturing environments
• Previous machine shop experience
• Knowledge of basic Quality Systems and good documentation practices
• Experience using statistical software (Minitab preferred)
• Strong analytical and problem-solving skills
• Demonstrated curiosity and initiative to identify and drive process improvements
• Effective communication skills and ability to work both independently and in cross-functional teams
• Familiarity with product/component documentation, inspection, testing, and Manufacturing Execution System (MES)
• Experience leading cross-functional teams and driving projects to completion
• Presentation skills for translating manufacturing performance and issues to peers and senior management

Skills

* Required skills