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Position Summary:                   

The Sr. QA specialist is responsible for regulatory and quality compliance of IVD products imported by Illumina Korea according to MFDS regulations and other relevant local regulations. In addition, this position is responsible for establishing and managing the quality system of the company to ensure medical devices sold by Illumina Korea are handled in compliance with local regulation and the quality is managed throughout product importing and distribution process.

Position Responsibilities:

• Follow Medical Device Act, IVD Medical Device Act, other relevant regulations, and internal compliance of Illumina.
• Follow quality policies and standards of Illumina Korea.
• Support the new Korean registrations and license amendments of IVD/Medical devices in Korea
• Arrange the foreign manufacturers’ inspection (Korea GMP) including the cooperation of site-audit based on requirements of Korea MFDS.
• Manage distributions following GSP compliance.
• Manage the process of 3PL warehouse tasks (i.e. incoming inspection, labeling process), ensure the conformity and maintain the relative records including product import, storage, labeling, UDI, delivery and distribution reporting.
• Obtain the quality data including product return, complaints, adverse events, recalls, risk management, CAPAs, NC, cooperate the data analysis and support the output.
• Support the regulatory reporting including recall, adverse event, safety information to MFDS.
• Provide a support of regulatory compliance aligning with marketing, sales, FSE and authorities (including NIDS, MFDS and KMDIA).
• Support the local labeling and requirements based on Medical Device and IVD regulations.
• Monitor local regulation changes and analysis and update to internal organizations about the impact.
• Conduct the review, audit, and documentation for on-boarding, monitoring and maintaining the local/APJ channel partner aligning with global SCP team.

Position Requirements:

• Good understanding in Medical device, IVD regulations and ISO 13485
• Proficient in writing and speaking English
• Good interpersonal, listening and communication skill.
• Collaborative and a team player

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Preferred Experience/Education/Skills:

• Typically requires a minimum of 6 years of Quality Assurance and/or Regulatory Affairs in Medical Device or IVD industry with a Bachelor’s degree (preferred science-major, like biologics or chemical background).

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.