Job Description
We are seeking a skilled professional to fill the role of Senior Engineer, Advanced Quality.
This is a permanent hybrid position with full benefits.
Key Responsibilities
* Collaborate with Engineering and Operations teams to define design requirements and develop manufacturing processes.
* Drive reliability engineering, human factors engineering, risk management, and design validation efforts.
* Evaluate compliance to quality systems, FDA regulations, ISO 13485, and other medical device standards.
Additional responsibilities include developing quality assurance documentation, guiding new product development teams through internal quality system requirements, and leading risk management for new development products.
The ideal candidate will possess a Bachelor's degree in a science, engineering, or related field, and have at least 2+ years of experience in Technical Engineering or Quality Engineering roles within R&D or manufacturing environments.
Responsibilities also include ensuring adherence to industry standards and guidelines, as well as collaborating with cross-functional teams to drive business results.