Senior R+D Quality Engineer

Job description

JOB SUMMARY: The Senior R + D Quality Engineer implements and enforces quality standards that align with industry best practices and regulatory requirements that are aimed at insuring robust and quality design and manufacturability of medical devices. ESSENTIAL/PRIMARY DUTIES: - Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations. - Acts as a recognized expert in risk management, leads all risk management processes and creates risk management documentation for (NPD) projects. - Acts as a recognized expert in design controls and creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). - Acts an expert in the design and process failure mode and effects analysis (FMEA) process and trains other engineers in the FMEA process. - Leads site-based quality department initiatives as a subject matter expert (SME). - Applies domain mastery to the application and advancement of engineering methods and tools. - Champions six sigma techniques and drives standardization through continuous process impro...