Director - Software Process Excellence

Job Title

Director - Software Process Excellence at BD Nogales Norte

Job Description Summary

Join Our Innovative Team at Software Technology Solutions (STS)! Are you ready to be part of a groundbreaking team that is transforming healthcare through cutting‑edge technology? BD’s global software innovation engine drives smart connectivity and data‑driven insights across devices. Our mission is to make a tangible difference in patients’ lives with world‑class technology capabilities.

Why STS?

Pioneering Projects : Build BD’s first enterprise cloud connectivity and data platform, laying the foundation for our smart connected care vision.

Work with Cutting‑Edge Technologies : Leverage AWS, Go, React, and Python to build innovative solutions at scale.

Central Innovation Team : Be part of a central software team where ideas quickly transform into impactful solutions.

Passion for Impact : Improve patient care and customer experience through innovative software development.

Supportive Leadership : Servant leaders dedicated to growth, continuous feedback, and empowerment.

Flexibility & Balance : Manage work and personal responsibilities effectively.

Job Description

BD is one of the largest global medical technology companies. BD invites you to learn, grow, and become your best self as a maker of possible. We are seeking a dynamic, experienced Director, Software Process Excellence to lead strategic and operational aspects of software development processes for Quality Management System (QMS) and regulatory compliance. The role will ensure software products meet all applicable regulatory, safety, and performance standards while fostering a culture of continuous quality improvement.

Job Responsibilities

• Collaborate with cross‑functional teams (Engineering, Product Management, Product Security, Legal, Regulatory, Quality Assurance) to embed quality and regulatory requirements into the product development lifecycle (SDLC) from concept through post‑market.
• Develop and maintain a comprehensive SDLC process aligned with BD’s strategic goals and regulatory requirements, enabling frequent releases of SaaS, multi‑tenant, cloud‑based products.
• Lead continuous improvement of the Quality Management System (QMS) processes in STS in compliance with relevant standards (e.g., ISO).
• Work closely with Regulatory Affairs to define and own industry‑specific regulatory guidance and frameworks for software development in a healthcare IT environment.
• Oversee all internal and external audits, ensuring audit readiness and traceability of documentation and actions.
• Ensure compliance with regulatory requirements, industry standards, and BD’s quality management system; evaluate and implement tools and automation to streamline quality and regulatory processes.
• Lead training, coaching, and development of the QA / RA team and STS teams to support a proactive, risk‑based approach to QA and RA.
• Serve as the primary point of contact for regulatory bodies and notified bodies, complaint handling, and other quality and regulatory reporting as needed.
• Contribute to the company’s strategic direction by providing quality and regulatory thought leadership.
• Establish strong stakeholder relationships with customers, business partners, and internal teams; communicate effectively with senior stakeholders to provide clarity on STS QMS and Regulatory work and progress.
• Champion the implementation of agile software development methodologies across the various STS teams.
• Conduct regular process reviews and assessments to identify areas for improvement and implement changes as needed.
• Ensure alignment with BD’s culture and values, contributing positively to the organizational culture.

Qualifications

Why Join Us

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, do what’s right, hold each other accountable, learn and improve every day. We welcome people with imagination and drive to reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive and find satisfaction in doing your part to make the world a better place.

Required Skills

Primary work location : USA CA – San Diego Bldg A & B. Hybrid preferred location.”

Salary Range Information

$179,200.00 – $322,500.00 USD Annual

Employment Type

Full‑time

Seniority Level

Director

Job Function

Engineering and Information Technology

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