Our client is an exciting, well-funded startup innovator in the cardiac repair space. The Quality Engineer/Sr Quality Engineer will be responsible for developing, applying, revising, and maintaining quality standards for the new product development process. We are partcularly interested in QEs with prior catheter and/or structural heart and/or surgical robotics product development experience! Responsibilities Oversee product quality during all stages of product development and production in a cleanroom manufacturing environment Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices Provide guidance on sterilization processes and validations to ensure product safety and compliance Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes Qualifications/Experience BS/MS in a relevant engineering discipline 6+ yrs of relevant medical device R&D and quality manufacturing experience In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices Experience with nonconforming material investigations and implementing effective CAPAs Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are desirable