Sr. Quality Specialist (1.6yr, Contractor)

We are the people who give possibilities purpose

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.

Job Description

I. Position Summary
This position is responsible for managing and ensuring that distribution quality and the quality system compliance requirements are met per the relevant standards, corporate & region, MFDS and other relevant local regulation requirements.

II. Key Responsibilities
A. Ensure t he distribution center are well managed in accordance with country and global company regulatory requirements.
• Responsible for ensuring the communication of, follow up and closure of Quality Hold Notices to assure timely release to prevent extended periods of products being on Hold.
• Evaluate and analyze labeling operating methods and procedures for quality control improvements, decides which methods and procedures to use and implements those procedures.
• Coordinate change control process to ensure handling change requests and its documentation in accordance with change control procedures. Ensure execution of change control process for MIDC, liaise with source plants/legal manufacturer for the required review & approval
• Addressing and hand ling issues related to non conformance in the distribution processes
• Ensuring timely and effective response to inquiries from DC.
• Conducting vis its to distribution centers to assess and enhance quality procedures.
• Managing global holds on products and ensuring zero escape.
• Reviewing and addressing an y damages in the distribution process

• Providing support related to the SAP system for quality related functions.

B. Ensure that the quality system complies with various requirements
• Managing changes with in the quality system
• Overseeing quality aspects related to B2B interactions
• Providing OJT for new BD Korea associates on quality processes.

C. Ensure that KGMP certificate process to support business continuity and launch in Korea market and all task owners are trained to adequately perform their assigned KGMP task
• Prepare the documents for GMP Document Review or On site Audit required for new/change/ renewal KGMP certification
• Communicate with stakeholders to ensure the completion of KGMP certification on a timely manner

D. Ensure implementation of applicable quality standards and governance processes
E. Ensure effective execution of processes conducted under the Quality Systems to accomplish expected requirements and performance.

F. Exhibit flexibility and adapt ability by managing assignments in accordance with project priorities and by altering the course of action when and where necessary.
G. Lead and /or facilitate and support Country, Regional and Corporate Quality Projects.

Why Join Us?

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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

KOR South Korea - Seoul HQ

Additional Locations

Work Shift