This Quality Assurance Engineer/Specialist will be entirely dedicated to supporting the MRIdian Linac installation process and Supplier Quality. This includes Design History Record, Supplier Quality and NCR management. In addition, this position needs to be flexible with travel needs. There is the possibility of having to spend significant time at the hospital during product installation. In this position, teamwork is critical. This individual will work heavily with the Install, Service and Engineering team and is expected to help create a productive team environment. This individual will be responsible for producing and reviewing documentation to ensure a high level of quality. Driving continuous improvement projects is expected to ensure continued world-class documentation as the regulatory environment changes.
This position will report to the Senior Director of Regulatory & Quality
• Be a strong cross-functional partner with the Install, Service, and Engineering team providing clear and productive guidance on Quality System requirements.
• Excellent technical writing and oral communication skills.
• Produce high-quality documentation that meets regulatory requirements.
• Experience in Software or Hardware Development in the medical device or an otherwise regulated industry.
• Ability to plan, organize, and implement concurrent tasks and projects.
• Excellent organizational, problem-solving, and analytical skills.
• Experience working in a cross-functional team environment.
• Ability to influence and interact with cross-functional team members.
• Ability to manage priorities in a fast-paced environment.
• Manage Supplier Quality documentation, Design History Records, Nonconforming Material Reports, Deviation Reports.
Experience and Skills:
• Understanding of and/or experience auditing to standards or regulations such as ISO 9001, ISO 13485, ISO 14971, IEC 62304, the FDA Quality System Regulation, Medical Device Directive and/or Canadian Medical Device Regulation
• Experience with cybersecurity standards or requirements
• Experience participating in ISO or regulatory audits
• Experience in Risk Management, FTA, FMEA
• Experience in supplier qualification or Computer System Validation
• ISO 13485 (Lead) Auditor certification, ASQ CQE, CQA and/or CSQE certification
• Medical device and related quality system industry experience required
• Knowledge of capital equipment from a Quality System perspective
• Bachelor's degree (or higher) in Physics, Engineering, or applicable physical science.
• Minimum 10 years of experience in medical device quality assurance or engineering.
• Proficiency utilizing business tools such as e-mail, Microsoft Word, Excel, and PowerPoint, and other productivity software.