BD (Becton, Dickinson and Company) Sr. Quality Specialist in South Korea HQ, South Korea
Job Description Summary
It is the responsibility for developing, managing, and ensuring that the quality system compliance requirements of BD Korea are met and focus on product complaints management and customer experience initiatives.
Be the point of contact for region and department for compliance management.
Develop professional relationships with the MFDS and other relevant government / non-government entities.
Liaise with MFDS to Monitor and follow-up newly announced or changed quality regulations
- Manage regulatory activities involving compliance to government regulations of the MFDS, as well as other regulatory bodies as required.
Manage all relevant Field Actions, including all negotiations with regulatory bodies and the local Business;
Manage all relevant Adverse Event notifications, including all negotiations with regulatory bodies and the local Business within the timeframs and guidelines specified;
Maintain necessary quality and compliance records.
Maintain and develop local QMS in compliance with local regulations of Medical Devices and drug.
Liaise with source plants or functional counterparts for regular quality monitoring activities including sterilization validation, sterility report, and annual quality evaluation.
Maintain and develop relationships with key customers and suppliers.
In conjunction with the Sales & Marketing team provide timely information for the preparation of tender submissions and quotations for customers.
Undertake project work as requested by the Quality Manager, Korea
Provide Korea compliance expertise to Regional and Global stakeholders as required.
Cross train in, and perform, other quality assurance support activities as required, such as Complaints Processing.
Support Quality Procedures and Policies as outlined in the Company’s Quality Manual. Including support for internal QA and corporate audits of the system.
Adhere to the requirements of the Quality Management System as maintained by BD Korea
Manage KGMP to support business continuity and launch in Korea market
Lead and manage key/escalated customer complaints/issues with the Business team and customers, inclusive of direct customer interactions to improve customer experience with products/services
Tertiary qualification in a relevant discipline (e.g. Science, Engineering, Medicine or Pharmacy).
Minimum 5 years corporate experience in a Regulatory Affairs/Compliance/Quality or similar role in a medium sized multinational organisation;
Knowledge of Korea MFDS/KGMP regulations, or demonstrated learning agility allowing the acquisition of such knowledge in a timely manner.
Advanced Excel skills;
Proven strong analytical skills to be able to identify and articulate business issues or opportunities on a timely basis;
Proven strong communication skills across a broad spectrum of business partners;
- Experience working in the healthcare industry.
Primary Work Location
KOR South Korea HQ - Seoul
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.