The Sr. 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.).
Job Description
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.
We have an immediate opening for a highly motivated, results-focused professional to join our team, and are growing our staff as a Sr. 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.
Please note this role is in the Quality organization and has no direct responsibility for software testing (V&V).
Business & Product Overview
Pyxis® medication technologies combine proven technology with actionable intelligence to prevent medication errors, help free up caregiver time to focus on patient care, increase the predictability of medication availability, and reduce inefficiencies in the med use process. At almost every point in the med use process, safety and efficiency can be increased with the comprehensive capabilities of the Pyxis® medication management system. Learn more about Pyxis®: https://www.bd.com/en-us/products-and-solutions/products/product-brands/pyxis
Broader Duties for this role include:
Responsible for being the core team quality representative for design control projects - new product development as well as sustaining efforts.
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.
Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval
Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets.
Ensures effective verification and validation of design specifications and requirements.
Reviews and ensures complete and comprehensive traceability of related design artifacts.
Active participant in the development of product requirement, product system hazard analysis and design reviews.
Proactively engage partners to drive consensus and resolve issues in a timely fashion.
Works collaboratively to drive root cause analysis of failures and structured problem solving for product development and manufacturing issues.
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 strong knowledge of quality engineering policies, principles and best practices
Understanding of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities
Applies comprehensive knowledge of software quality concepts within the software development lifecycle
Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place
Applies knowledge and skills to a wide range of situations
Desired Characteristics
Software development experience within a regulated environment
Strong background in software development methodologies
Experience working in an iterative development environment like Scaled Agile Framework (SAFe) esp SAFe Certifications
Thorough understanding of the risk management and quality by design
ASQ Certified Software Quality Engineering Certification (CSQE) or equivalent
Attentiveness to details with strong organizational skills
Ability to work proactively and independently
Ability to manage multiple priorities and be efficient in time management
Excellent verbal communication and interpersonal skills with the ability to work in a team environment
Proficiency in Excel, Word, and other desktop/general business systems
Qualifications:
Bachelor's degree in a relevant degree field (engineering)
Minimum 3 years' experience with emphasis on R&D development, Quality Engineering and Design Controls
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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/Affirmative Action Employer. We 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.
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Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
