BD is looking to solve the problem of ensuring software quality across its STS and Incada divisions by hiring a Director of Software Quality who will lead strategic quality initiatives, manage software quality engineering teams, and ensure compliance with regulatory standards and internal quality systems.
Requirements
- Expert knowledge of software development lifecycle and test methodologies.
- Strong understanding of design controls, risk management, and product security.
- Familiarity with regulatory standards including ISO 13485, IEC 62304, and 21 CFR.
- Experience in Agile/SAFe methodologies is preferred
- Experience in Cloud/SaaS software product development is preferred
Responsibilities
- Leading the development, establishment and maintenance of Quality Assurance and Engineering programs in the STS team.
- Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and development.
- Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.
- Align software validation practices across BD.
- Manage quality metrics and present them in management reviews.
- Provide Design and Development leadership during FDA and Notified body site inspections.
- Interface with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors
Other
- Bachelor's degree in engineering, computer science, or life sciences.
- 15+ years of experience in software design and development within Medical Device regulated industry.
- Experience managing software quality engineering teams and leading complex software projects.
- ASQ certifications (CQA, CQE, CSQE, CMQ) are a plus.
- Excellent leadership, project management, and cross-functional collaboration skills.
