Quality Engineer

Job Description: Quality Engineer

The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment.

RESPONSIBILITIES

• Support sustaining engineering through operational quality activity - material control, process development, inspection/acceptance activity, nonconforming material control, equipment qualification, and supplier management
• Participate in risk management activity - analysis and documentation applied throughout the product development process
• Inspect and test materials, equipment, processes, and products to ensure quality specifications are met
• Support test method development and qualification activity
• Support the design engineering teams for catheter, hardware, and systems throughout the design control process
• Design and implement quality system processes to comply with regulatory standards

SKILLS AND EXPERIENCE

• Degree in mechanical or biomedical engineering or related applicable engineering field
• 3-5 years of experience in quality engineering, quality assurance, or a related role in a regulated industry
• Experience in catheter, hardware, and system production, or with similar medical devices, while working with a Quality Management System
• Applied understanding of 21 CFR 820 and ISO 13485:2016
• Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods
• Experience in risk management and design control
• Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills