The Quality Engineering Intern links the needs of both the Quality and Engineering Departments.
• Supports Quality and Development departments such as design control, quality assurance/documentation control, supplier management, product reliability, and regulatory assurance.
• Facilitates documentation control activities as part of the QMS Document Control Process
• Supports the incoming receiving and service and repair with our Contract Manufacturers (CM) and other product suppliers’ activities, including but not limited to transfer of documentation/materials, reviewing drawings and BOMs for approval, and reviewing labeling and Design History Records prior to the release of product from CM.
• Closely works with the other Departments to support the Quality Management System.
• Works with Procurement to ensure proper identification and traceability of production products.
• Supports records management and record retention to support the Quality Management System.
• Support quality compliance of FDA’s QSR (General Controls and 21 CFR Part 820) and ISO 13485 compliance.
• Stay current on applicable ASTM and other quality standards defined by applicable FDA products.
• Working towards a technical degree (mechanical or biomedical engineering related) or equivalent
• Engineering experience in technical areas involving critical thinking, detailed oriented, and technical skills.
• Ideally, at least a Junior or Senior level at a University.
• Must possess excellent interpersonal and people-management skills.
• Excellent written and verbal communications skills, including the ability to be articulate, concise, compelling, and diplomatic.
• Interdisciplinary skill sets in electronic, mechanical, and optics a plus.
• Training is defined in Competence, Awareness, and Training procedure with additional training based on position as needed.
• Additional training may be defined by Quality / Regulatory lead based on job assignment.
If you are interested in this opportunity, please submit your resume and contact information here. Feel free to let us know why you are interested in this position.