The Quality Specialist I is accountable for distribution quality systems, nonconforming and hold product disposition, and ensuring compliance with procedures and external regulatory requirements.
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.
Job Responsibilities:
Responsible for monitoring assigned quality system performance through established metrics and/or quality objectives.
Collaborate with functional process owners to train, mentor and/or facilitate QMS requirements
Continuous process improvement.
Maintain awareness of and follows applicable corporate quality procedures.
Maintain awareness of and follows applicable external regulatory requirements.
Responsible for quality systems as a Subject Matter Expert (SME), ensuring application and compliance to the following Quality Systems in a manner that meets the scope of storage and distribution processes.
Holds and product disposition and movement within the WMS/SAP
Zero Escape
Intracompany Claims
QMS Audits
Metric Data Analysis
Operations Support
Designated Representative License
SME for ISO 13485, 21 CFR 820, and Corporate Policies / Procedures when appropriate.
Customer service claims.
Responsible for ensuring site is meeting the terms and obligations of local wholesale drug licenses as the designated representative.
Be aware of the other positions' responsibilities to assist in times of urgency, breaks, absences, or vacation.
Education and Experience:
Bachelor's degree science preferred; or,
Associates degree, or a combination of equivalent education and experience, required in lieu of a Bachelor's degree.
3 years experience in a regulated environment and proficiency with SAP, WMS, and other ERP platforms, preferred.
Industry Recognized certification in a Quality System Element or specialty (e.g., ASQ Certified Quality Auditor, etc.), preferred.
Knowledge and Skills:
Self-motivated and directed, requiring minimal supervision.
Demonstrated ability to work in teams to obtain results.
Effective skills in analytical thinking and problem solving.
Highly proficient in the use of a PC, with strong knowledge of Microsoft Office Suite.
Expert with SAP, WMS, and other ERP platforms.
Excellent technical writing skills.
Physical Demands:
The physical demands described are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, in accordance with the Americans with Disabilities Act of 1990 and applicable state and local laws. While performing this job, the associate is regularly exposed to episodes of walking, standing, stooping, kneeling, balancing, crouching, reaching, pushing/pulling, grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers. The associate may occasionally be required to climb. The job may require lifting over 50lbs in some areas but not all. Associate must have normal field of vision corrected to 20/40 in each eye and must have hearing sufficient to safely operate MHE [Material Handling Equipment] in a manufacturing/distribution environment.
Work Environment:
This position typically works in a normal office environment with a warehouse / supply chain environment. The noise level in the work area is quiet to moderate. At times, position may be required to support operational activities in the distribution center.
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.
#earlycareer
Required Skills
Optional Skills
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Primary Work Location
USA MD - Sparks - 26 Loveton Circle
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.
