What are the responsibilities and job description for the Quality Engineer - Dispensing Installation (Remote) position at CareFusion Manufacturing, LLC?
Job Description Summary
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 Quality Engineer is a permanent full time role that will be a key member of a team focused on improving the Quality and compliance of the Dispensing Implementation process. This role will work with the Dispensing Implementation teams to document and suggest compliance-related improvements or changes to that process. The intent of this role is to bring the Dispensing Implementation process to a state of compliance that would pass an external regulatory agency inspection.
Duties include:
Evaluating the Dispensing Implementation process against regulatory requirements associated with CFR 820.200 and international regulatory requirements.
Contributing to a cross-functional effort to develop and implement the plan to improve the compliance state of the process.
Communicate weekly status to the Quality and SDS leadership teams.
Compliance to all service record documentation requirements.
Adherence to BD Inspire Quality Processes
Driving effective and efficient installation and implementation execution.
Job Family Summary
Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services.
What is expected of you for success in your role:
Demonstrates strong knowledge of quality engineering policies, principles and standard processes
Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision
Represents Quality organization on project Core Team(s)
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)
Acts as a resource for colleagues with less experience
Collaborates across functions and TGS to drive effective and confident compliance.
Qualifications:
Qualified candidates will have a Bachelor’s degree in a relevant degree field (engineering) and minimum 5 years experience in a Quality role in FDA regulated environments.
Demonstrated history completing quality/compliance improvement projects in an FDA regulated environment is preferred.
Demonstrated experience with installation of medical devices with embedded software is preferred.
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
Proficiency in Excel, Word, and other desktop/general business systems
Quality Engineering Certification (ASQ) or equivalent (preferred)
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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&DAdditional 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.
Salary Range Information
$102,000.00 - $168,200.00 USD AnnualSalary : $102,000 - $168,200