James Dssbb currently serves as a Principal Engineer and Project Manager at RQM+, where he leverages over 20 years of extensive experience in quality engineering and project management within the medical device, automotive safety, and defense sectors. His role primarily focuses on overseeing the development...
James Dssbb currently serves as a Principal Engineer and Project Manager at RQM+, where he leverages over 20 years of extensive experience in quality engineering and project management within the medical device, automotive safety, and defense sectors. His role primarily focuses on overseeing the development and regulatory compliance of Class III implantable cardiac products and their delivery systems for a prominent client based in Galway, Ireland. James's expertise in navigating complex regulatory landscapes, including interactions with agencies such as the FDA, NIOSH, and FAA, positions him as a vital asset in ensuring that products not only meet stringent safety and efficacy standards but also align with customer requirements and industry best practices.
In his current projects, James employs his Six Sigma Master Black Belt skills to drive process improvement initiatives and optimize design controls, ensuring that every phase of product development adheres to rigorous quality systems. His proficiency in Hazard Analysis and Critical Control Points (HACCP) and Design of Experiments (DOE) enables him to implement robust testing protocols that mitigate risks and enhance product reliability. Additionally, James is adept at software documentation, which is critical in maintaining compliance and facilitating seamless communication among cross-functional teams. His commitment to excellence and innovation in liquid handling processes further underscores his capability to lead complex projects from conception through to successful market launch, ultimately contributing to advancements in cardiac care and patient safety.
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