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QRC Manager (Maternity cover: 24 months contract) at Getinge

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

03 Jan, 26

Salary

0.0

Posted On

05 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Registration, Quality System, ISO13485, KGMP, Internal Audit, Compliance, Regulatory Submissions, Technical Dossier, Audits, Inspections, Ad-hoc Duties

Industry

Medical Equipment Manufacturing

Description

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Mainly MFDS Product registration for License and besidely, Korea GMP Inspection, Internal Audit and Compliance to local/ company regulations, maintaining ISO13485 and Getinge QMS requirements. Duties and Responsibilities Preparation of product technical dossier packages for regulatory submissions by working with respective BA QRC team. Develop and maintain site Quality System and procedures to comply with KGMP import requirements. Maintain and comply with ISO13485 and Getinge QMS requirements. Conduct or support internal/ External audits and inspections, e.g., ISO13485, KGMP. Update KGMP on status of Getinge implantable devices imported and distributed by distributors. Perform ad-hoc duties as assigned by the line manager and/or the Company. About us  With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Responsibilities

The QRC Manager will prepare product technical dossier packages for regulatory submissions and maintain compliance with KGMP and ISO13485 requirements. They will also conduct internal and external audits and inspections.