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SalaryThe 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
- 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
