[Hiring] Regional Quality Assurance Lead @Agilent Technologies

Role Description

The Manager, Regional Quality Assurance (QA) will serve as the registered IVD Medical Device Quality Manager(품질책임자) for Agilent Korea. The statutory and operational responsibilities associated with the Korea Quality Manager(품질책임자) role will be the primary responsibility of this position. Additional regional responsibilities may also be performed to provide oversight, processes, and tools to the operating companies and channel partners (importers, distributors, sellers/resellers, dealers, service providers, sales & marketing agents) who execute commercial quality activities for Agilent in the Asia Pacific (APAC) region.

This role involves working with cross-functional teams to execute, improve, maintain and monitor these regional quality activities. The Manager will report directly to the International Quality Lead. The candidate must meet the applicable statutory qualification requirements to serve as the registered Quality Manager for IVD medical devices in South Korea.

Qualifications

• Bachelor of Science (BS or BSc) degree in Engineering, Science, Life Science, Medical, Clinical Laboratory Science, or another relevant technical discipline is required, or directly equivalent experience in Quality Assurance.
• Advanced degrees, including an MBA or a relevant professional certification in Quality Management, Engineering, Life Sciences, Medical Devices, or Regulatory Affairs are preferred.

Requirements

• Minimum of 8 years’ experience in Quality Assurance, Regulatory Affairs, and Commercial Quality, including substantial hands-on experience in medical device or IVD Quality Assurance and import quality operations.
• Prior experience serving as, or directly supporting, a registered Quality Manager (품질책임자) for a medical device or IVD manufacturer or importer in South Korea is strongly preferred.
• Experienced in Regulated Product Environments, such as Medical Devices, In-Vitro Diagnostic Devices (IVDs), BioPharma, or other related Life Science industry, with medical device or IVD experience strongly preferred.
• Experienced in conducting and/hosting audits and inspections, with strong knowledge of applicable Korean medical device and IVD requirements, KGMP, and relevant international standards and regulations, including US FDA CFRs, EU IVDR, MDSAP requirements, ISO 13485, ISO 14971, ISO 9001, and the application to establish a strong QMS.

Benefits

• This job has a full time weekly schedule. It includes the option to work remotely.
• Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
• Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Additional Details

• Travel Required: Occasional
• Shift: Day
• Duration: No End Date
• Job Function: Quality/Regulatory