The 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 quality engineering principles are applied to new product development and sustaining engineering projects.
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.
The 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 quality engineering principles are applied to new product development and sustaining engineering projects.
Duties 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.
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 Quality Engineers to ensure effective verification of design specifications and requirements.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams
Active participant in the development of product requirement, product system hazard analysis and design reviews.
Lead/own or support CAPA investigations and CAPA closures.
Ensure product technical files and Design History Files are complete and auditable.
Follow Quality System Regulations and established procedures
Responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints.
Proactively engage partners to drive consensus and resolve issues in a timely fashion.
Provide statistical support and expertise and analytical problem solving for product
Acts as a resource for colleagues with less experience.
Qualifications:
Requires a minimum of a BS degree in science, engineering, or relevant subject area
Minimum 8 years' experience with emphasis on R&D development, Quality Engineering and Design Control
Knowledge, Skills, Abilities:
Proficient in Microsoft Office suite (Excel, Word, PowerPoint).
Excellent verbal and written communication skills.
Attentiveness to details with strong organizational skills
Ability to work independently as well as part of a team.
Ability to use root cause analysis tools and execute corrective action plans
Knowledge of quality systems and regulatory standards requirements including 21 CFR 820 , ISO 13485, ISO 14971
Knowledge in lean tools and techniques (Practical Problem Solving, A3, PFMEA and /or Fishbone diagrams)
Familiarity with GMP and regulatory requirements for medical devices.
Experience with hardware development within a regulated environment is preferred.
Thorough understanding of the risk management and quality by design is preferred
Experience in production and process control is preferred
Quality Engineering Certification (ASQ) or equivalent is preferred
Experience in Project / Program Management preferred
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.
Required Skills
Optional Skills
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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.
