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.
Position Summary:
The Sr. Quality Systems Specialist actively supports the development, implementation, and monitoring of an element or elements of the Quality Management System (QMS), including but not limited to Corrective and Preventive Action (CAPA), Document Control, and Training and Qualification, and various other elements for the site / Business unit. This role monitors and maintains applicable procedures for that element of the QMS, and develops, implements, or manages applicable instructions, as necessary or directed.
The Sr. Quality Systems Specialist provides guidance and training to associates for processes associated with their responsible QMS element, facilitates meetings and escalation, and supports departmental and organizational goals and processes.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Works within the designated QMS element in accordance with process and procedural requirements
Collaborates with Quality & other departments
Supervision over document control / training coordinator
Participates in meetings and escalations
Administrate the electronic data management system
Act as the system administrator, assigning seats to users, and ensuring all users are trained
Act as the Item Administrator for JDE, which may include attending monthly conference calls, managing and coordinating updates to JDE.
Support New Product Design and Development by creating new raw materials specification and documents for new product lines. Participates in regulatory compliance audits and inspections to assess compliance with ISO standards (specifically ISO 13485), EU MDR, and any additional internal regulations and internal requirements.
Act as Site CAPA Leader and leads investigations, as necessary
Coordinates and conducts information and training sessions applicable to their designated QMS element for associates, as necessary
Administer and maintain the site training program. Ensure required training is assigned based on internal matrices, business unit, and corporate requirements.
Oversees/Leads monitoring and maintenance of activities associated with, and Quality Records generated from their designated QMS element in accordance with process and procedural requirements and reports upward and outward accordingly
Assists in developing integrated implementation strategies for a variety of QMS elements
Demonstrates expert QMS skills and knowledge
Education and Experience:
Bachelor’s Degree in a related area / technical field OR comparable years of experience
5+ years relevant experience
ERP system (JDE) experience preferred
Experience in an FDA regulated environment preferred
Demonstrated experience in root cause analysis & problem solving preferred
Experience using Trackwise, Master Control (EDMS), & Teamcenter (EDMS) software preferred
Experience with statistics 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.
Primary Work LocationUSA IL - Carol StreamAdditional LocationsWork Shift