Korean Bilingual - Quality Engineer 1

Job Summary
We are seeking a highly motivated and detail-oriented Korean Bilingual - Quality Engineer 1 to join our dynamic team. In this role, you will be instrumental in ensuring our products meet rigorous quality standards and comply with industry regulations. Your bilingual skills will facilitate seamless communication across diverse teams, while your expertise in quality systems will drive continuous improvement initiatives. This position offers an exciting opportunity to contribute to innovative manufacturing processes, uphold compliance with global standards, and support the delivery of safe, high-quality products to our customers.

Responsibilities

• Conduct comprehensive quality inspections and audits throughout the manufacturing process to ensure adherence to ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards.
• Support the development, implementation, and maintenance of quality management systems (QMS) and quality assurance protocols.
• Perform detailed analysis of quality data to identify trends, root causes, and areas for improvement; lead corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams on project management tasks related to product development, process validation, and compliance initiatives.
• Lead or participate in internal and external quality audits, ensuring compliance with industry standards and regulatory requirements.
• Facilitate bilingual communication between Korean-speaking teams and global stakeholders to ensure clarity in quality expectations and documentation.
• Assist in training staff on quality control procedures, inspection techniques, and regulatory updates to foster a culture of quality excellence.

Experience

• Bilingual proficiency in Korean and English is essential for effective communication across teams and documentation purposes.
• Proven experience working within manufacturing environments focused on medical devices or food production that adhere to ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards.
• Demonstrated expertise in conducting quality audits, inspections, and implementing quality systems within regulated industries.
• Strong analysis skills with the ability to interpret complex data sets for continuous improvement efforts.
• Familiarity with QA/QC processes, quality management principles, and project management methodologies.
• Prior experience supporting compliance with industry-specific standards such as ISO 13485 or FDA regulations is highly desirable. Join us in a role where your dedication to quality will directly impact product safety and customer satisfaction! We value energetic professionals who thrive on collaboration, precision, and continuous learning.

Pay: $38.73 per hour

Work Location: In person