Sr Quality Engineer

The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment. The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams. Perform Quality Engineering activities related to product development and ongoing cleanroom build support Ensure NPD processes comply with the quality system and applicable regulatory standards Update risk management and design control files and maintain relevant quality documentation Develop and execute test method validations and qualification plans Support design verification and facilitate process validation and commercialization activities related to multi-site transfer Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing Other duties assigned by Leadership Job Summary The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment. The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams. Perform Quality Engineering activities related to product development and ongoing cleanroom build support Ensure NPD processes comply with the quality system and applicable regulatory standards Update risk management and design control files and maintain relevant quality documentation Develop and execute test method validations and qualification plans Support design verification and facilitate process validation and commercialization activities related to multi-site transfer Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing Other duties assigned by Leadership Roles & Responsibilities: The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment. The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams. Perform Quality Engineering activities related to product development and ongoing cleanroom build support Ensure NPD processes comply with the quality system and applicable regulatory standards Update risk management and design control files and maintain relevant quality documentation Develop and execute test method validations and qualification plans Support design verification and facilitate process validation and commercialization activities related to multi-site transfer Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing Other duties assigned by Leadership Education & Experience Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience Strong preference for candidates with experience in NPD, Design Assurance (DA), and Quality Engineering Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred Relevant experience in product development, quality assurance, and/or related fields Knowledge and understanding of Engineering and Quality principles, theories, and concepts Understanding of ISO 13485 Experience developing, updating, and maintaining technical content of risk management files Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus Experience in test method development including validation and/or fixture development Solid problem-solving, organizational, analytical, and critical thinking skills Good documentation and communication skills with attention to detail Ability to build productive working relationships and interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment #J-18808-Ljbffr