Quality Ops Analyst

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:

The 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.
• Support quality policies and standards of Illumina Korea.
• Support the new registration application and registration 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 4 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).

Illumina believes that everyone has the ability to make an impact, and 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.