Quality Engineer II

Responsibilities may include the following and other duties may be assigned

• Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
• Subject matter expert in risk management for designated medical device products or platforms.
• Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
• Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
• Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports.
• Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
• Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.
• Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR.
• Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis.
• Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies.
• Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab)
• Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
• Independently review all deliverables to ensure compliance with development process and the standard.