Director - Software Process Excellence (San Diego)

4 weeks ago

San Diego CA, United States BD Full time

Director - Software Process Excellence
BDs Software Technology Solutions (STS) division is looking for a dynamic, experienced leader to serve as Director of Software Process Excellence. This role will own the strategic and operational aspects of our software development processes, ensuring our products meet all applicable regulatory, safety, and performance standards while fostering a culture of continuous quality improvement.
As a key member of BDs STS leadership team, you will shape and implement SDLC processes across the enterprise. Your expertise in agile software development methodologies, regulatory compliance, and process excellence will be essential to deliver highquality SaaS and multitenant cloud solutions in the highly regulated healthcare IT landscape.
Collaborate with crossfunctional teams to embed quality and regulatory requirements into the product development lifecycle.
Develop and maintain a comprehensive SDLC process that aligns with BDs strategic goals and regulatory requirements.
Lead continuous improvement of the Quality Management System (QMS) processes in STS in compliance with relevant standards.
Work closely with Regulatory Affairs to define and own industryspecific regulatory guidance and frameworks for software development.
Ensure compliance with regulatory requirements, industry standards, and BDs quality management system, evaluating and implementing tools and automation to streamline processes.
Lead training, coaching, and development of the QA/RA team and STS teams to support a proactive, riskbased approach to QA and RA.
Serve as the primary point of contact for regulatory bodies, complaint handling, and other quality and regulatory reporting as needed.
Communicate effectively with senior stakeholders to provide clarity on STS QMS and regulatory work progress.
Champion agile software development methodology across STS teams.
Ensure alignment with BDs culture and values, contributing positively to the organizational culture.
Bachelors degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Masters or RAC certification preferred).
~10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device or SaMD industry.
~ Strong understanding of risk management, software lifecycle validation, and design controls for medical device software.
~ Familiarity with Agile methodologies (Scrum, Kanban) and frameworks (SAFe).
~ Personal courage in leadership and decisionmaking.
~ remote employees should be ready to travel once a month to San Diego.

BD is one of the worlds largest medical technology companies. We are dedicated to inventing and delivering the next generation of lifesaving medical technology. At BD, youll discover a culture that values learning, growth, and the opportunity to make a tangible difference in patient care.
USA, CA San Diego, Building A & B
Fulltime
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