Job Description

　　The Quality specialist will be responsible for providing oversight and guidance for the quality systems and compliances for products being imported into South Korea within Thermo Fisher Scientific, and domestic sales business.

　　Reports to Quality Manager

　　Working location : Incheon (Youngjong)

　　Key Responsibilities:

　　Maintains and updates the QMS system to ensure compliance with current regulations and standards and approval according to ISO 13485.

　　Maintains warehouse management for facility and environment according to ISO 13485 or equivalent standard

　　Manages Post market surveillance (Product hold, Recall and Adverse event reporting) for the imported medical devices / IVD

　　As a process owner of the quality documents and quality records, ensure the latest version of quality documents should be maintained and used at work as well as quality records management

　　Responsible for that ISO certification and related activites performed as professional and efficient survey, validation, etc. & supports quality management review meeting

　　Be key auditee from internal and external audit regarding Quality Management System.

　　Management of customer facing quality processes to provide timely and professional reply to customer complaints, requests for information, host of audits, quality agreements etc.

　　Management of internal audit program and identification of nonconformance observations and opportunities for improvement in the quality system.

　　Maintain Corrective actions and preventive actions (CAPA) process and monitors its performance.

　　Manages Change Management process and monitors its performance.

　　Provides leadership in steering all quality management systems activities as Training, Change Management Process, Corrective/Preventive Action system and Internal Audit program and management of associated boards and tier board meetings are conducted per defined time interval.

　　Ensures Management is informed in a timely manner of changes / trends in the Quality Management System regulations and standards.

　　Supervise Label & UDI management for the imported medical devices / IVD

　　Supervise RDR (Reporting Distribution Records) for the imported medical devices / IVD

　　Qualifications:

　　Bachelor degree or higher degree in related field

　　More than 10 years working experience in quality in the medical device or medicine field is preferred

　　Bioscience, Engineering Background is preferred

　　In-depth knowledge of ISO9001, 13485 or GMP

　　Strong oral and written communication in English and Korean

　　Independent, proactive and able to work in a matrix environment

　　Good root cause analysis and problem solving skill

　　Well organized and structured.

　　Highly motivated and self-directed requiring minimal supervision including the ability to work on multiple project

　　Ability to use some or all the following PC applications: Word, Excel, PowerPoint.

　　Benefits:

　　We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

　　EEO/Reasonable Accommodation:

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.