BD
Job Description Summary We have an immediate opening for a highly motivated, results-focused professional to join our team, and are growing our staff as a Senior Staff Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings and prepare reports for key quality metrics.
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us.
The Senior Staff Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects. This position also supports broader QMS activities (Audit, CAPA, Data Analysis, Installation & Servicing, Complaint Handling, etc.).
Business & Product Overview BD’s Pharmacy Automation Central Fill solutions are designed to transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation. These centralized facilities serve networks of retail pharmacies, hospital systems, care facilities, and mail-order services, enabling efficient medication distribution from a single location.
Responsibilities
Serve as the quality cornerstone for multi-functional design teams, championing excellence in both new product development and sustaining engineering efforts
Orchestrate comprehensive quality strategies throughout the design control lifecycle—from initial planning through verification and validation to risk management and regulatory compliance
Provide expert guidance on quality system implementation, with specialized focus on design controls
Conduct thorough reviews of design documentation, ensuring meticulous compliance with Quality Management System requirements and documentation protocols prior to final approval
Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets
Ensure robust verification and validation protocols that definitively confirm design specifications and requirements
Maintain comprehensive traceability matrices across all design elements, creating a clear line of sight from requirements to implementation
Give vital quality insights during product requirement development, system hazard analysis, and critical design reviews
Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently
Lead sophisticated root cause investigations and structured problem-solving initiatives for both development and manufacturing challenges
Curate impeccable technical files and Design History Files that withstand regulatory scrutiny
Orchestrate continuous improvement initiatives by facilitating multi-functional collaboration and innovation
Demonstrate mastery of quality engineering principles, methodologies, and industry standards
Apply comprehensive understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304—with minimal direction
Leverage deep knowledge of software quality assurance throughout the development lifecycle
Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies
Use advanced ... (the original had typo "advasophisticatedlity engineering tools" but keep content)
Serve as a mentor and knowledge resource for developing quality professionals
Differentiating Qualities
Demonstrated success applying Lean or Six Sigma methodologies to streamline software design control processes, with practical implementation examples
Experience championing cybersecurity initiatives within regulated medical device environments
Consistent track record supporting hardware development and integrating hardware/software systems within design controls frameworks
Great foundation in modern software development methodologies
Experience thriving in iterative development environments such as Scaled Agile Framework (SAFe), particularly with SAFe certifications
Comprehensive understanding of risk management principles and quality-by-design approaches
Qualifications
Bachelor’s degree in a relevant degree field such as engineering and 15 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls OR
Master’s degree in a relevant degree field such as engineering and 10 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
Ability to travel up to 10%
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.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us 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.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift
#J-18808-Ljbffr
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us.
The Senior Staff Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects. This position also supports broader QMS activities (Audit, CAPA, Data Analysis, Installation & Servicing, Complaint Handling, etc.).
Business & Product Overview BD’s Pharmacy Automation Central Fill solutions are designed to transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation. These centralized facilities serve networks of retail pharmacies, hospital systems, care facilities, and mail-order services, enabling efficient medication distribution from a single location.
Responsibilities
Serve as the quality cornerstone for multi-functional design teams, championing excellence in both new product development and sustaining engineering efforts
Orchestrate comprehensive quality strategies throughout the design control lifecycle—from initial planning through verification and validation to risk management and regulatory compliance
Provide expert guidance on quality system implementation, with specialized focus on design controls
Conduct thorough reviews of design documentation, ensuring meticulous compliance with Quality Management System requirements and documentation protocols prior to final approval
Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets
Ensure robust verification and validation protocols that definitively confirm design specifications and requirements
Maintain comprehensive traceability matrices across all design elements, creating a clear line of sight from requirements to implementation
Give vital quality insights during product requirement development, system hazard analysis, and critical design reviews
Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently
Lead sophisticated root cause investigations and structured problem-solving initiatives for both development and manufacturing challenges
Curate impeccable technical files and Design History Files that withstand regulatory scrutiny
Orchestrate continuous improvement initiatives by facilitating multi-functional collaboration and innovation
Demonstrate mastery of quality engineering principles, methodologies, and industry standards
Apply comprehensive understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304—with minimal direction
Leverage deep knowledge of software quality assurance throughout the development lifecycle
Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies
Use advanced ... (the original had typo "advasophisticatedlity engineering tools" but keep content)
Serve as a mentor and knowledge resource for developing quality professionals
Differentiating Qualities
Demonstrated success applying Lean or Six Sigma methodologies to streamline software design control processes, with practical implementation examples
Experience championing cybersecurity initiatives within regulated medical device environments
Consistent track record supporting hardware development and integrating hardware/software systems within design controls frameworks
Great foundation in modern software development methodologies
Experience thriving in iterative development environments such as Scaled Agile Framework (SAFe), particularly with SAFe certifications
Comprehensive understanding of risk management principles and quality-by-design approaches
Qualifications
Bachelor’s degree in a relevant degree field such as engineering and 15 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls OR
Master’s degree in a relevant degree field such as engineering and 10 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
Ability to travel up to 10%
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.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us 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.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift
#J-18808-Ljbffr