BD Nogales Norte
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Director of Software Quality
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BD Nogales Norte Job Description Summary
This position is part of the Central Quality team and reports to the Sr Director of Quality Engineering. The role is responsible for software quality across STS and Incada and serves as a member of the STS leadership team. The Director of Software Quality will lead strategic quality initiatives, manage software quality engineering teams, and ensure compliance with regulatory standards and internal quality systems. 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. Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively. Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.). 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 Maintain effective design-related Quality Metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work. Actively identify improvements to the processes within the QMS to enhance both compliance and quality. Assess resource needs to align the required level of quality support provided Education and Experience
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. Knowledge And Skills
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. Excellent leadership, project management, and cross-functional collaboration skills. Ability to influence without direct authority and manage organizational change. Excellent communication skills (up, down, and outward) Experience in Agile/SAFe methodologies is preferred Experience in Cloud/SaaS software product development is preferred 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, we do what’s right, we hold each other accountable, and learn and improve every day. Salary Range Information
$179,200.00 - $322,500.00 USD Annual BD is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and supportive work environment that values the contributions of all employees.
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Director of Software Quality
role at
BD Nogales Norte Job Description Summary
This position is part of the Central Quality team and reports to the Sr Director of Quality Engineering. The role is responsible for software quality across STS and Incada and serves as a member of the STS leadership team. The Director of Software Quality will lead strategic quality initiatives, manage software quality engineering teams, and ensure compliance with regulatory standards and internal quality systems. 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. Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively. Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.). 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 Maintain effective design-related Quality Metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work. Actively identify improvements to the processes within the QMS to enhance both compliance and quality. Assess resource needs to align the required level of quality support provided Education and Experience
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. Knowledge And Skills
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. Excellent leadership, project management, and cross-functional collaboration skills. Ability to influence without direct authority and manage organizational change. Excellent communication skills (up, down, and outward) Experience in Agile/SAFe methodologies is preferred Experience in Cloud/SaaS software product development is preferred 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, we do what’s right, we hold each other accountable, and learn and improve every day. Salary Range Information
$179,200.00 - $322,500.00 USD Annual BD is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and supportive work environment that values the contributions of all employees.
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