Job description summary
Job description
Be part of something bigger!
Bd is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of careWe have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The staff software quality engineer is a key member of the new products development team and is responsible for qa-related r&d activities from research through product launchThis position ensures that quality engineering principles are applied to new product development and sustaining engineering projectsThis is a home-based position!
Duties include:
Responsible for being the primary quality representative for design control projects – new product development as well as sustaining efforts.
Responsible for review and/or approval of design history file documentation in support of design controls.
Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
Work closely with program managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
Works together with other quality engineers to ensure effective verification of design specifications and requirements.
Monitors and ensures compliance with company policies and international standards.
Reviews and approves change orders and/or electronic release authorizations for new releases or design enhancements.
Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation.
Active participant in the development of product requirements, product system hazard analysis and design reviews.
Work closely with product management to ensure effective validation of user needs.
Ensure product technical files and design history files are complete and auditable.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.
What is expected of you for success in your role?
Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
Applies intermediate understanding of regulatory requirements (cgmp, fda, iso, etc.) to support work with little or no supervision
Applies comprehensive knowledge of software quality concepts within the software development lifecycle
Comprehensive knowledge in software development, including knowledge of software engineering, as well as test processes and methods
Able to pull reports (queries), interpret trends and make recommendations for improvement to existing processes and tools
Uses comprehensive expertise to help improve and streamline the software quality or development process
Represents quality organization on cross-functional product development core team(s)
Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers
Considered expert in critical areas of the system and influences project test solutions
Can apply understanding of the inter-workings of the application code under test
Participates in design reviews
Applies software engineering knowledge to tasking (e.gCode and detailed design reviews, low-level white box testing, etc.)
Applies knowledge and skills to a wide range of standard and non-standard situations
Qualifications:
Qualified candidates will have a bachelor’s degree in a relevant degree field (engineering) and minimum 8 years’ experience with emphasis on r&d development and software quality
Engineering and design control
Experience in software development, and experience within a regulated environment is preferred
Experience in hardware development is preferred
Thorough understanding of the risk management and quality by design
Attentiveness to details with strong organizational skills
Ability to work proactively and independently
Ability to multi-task and efficient in time management
Excellent verbal communication and interpersonal skills with the ability to work in a team environment
Why join us?
A career at bd means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to workHere our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding cultureOur total rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about bd visit https://jobs.bd.com/
Becton, dickinson and company is an equal opportunity/affirmative action employerWe do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary work location
Usa ca - san diego tc bldg c&d
Additional locations
Work shift
