QRC Manager

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.

Function Summary

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 (Business Area) QRC team.
• Develop and maintain site Quality System and procedures to compy with KGMP import requirements.
• Maintain and comply with ISO13485 and Getinge QMS requirements.
• Conduct or support internal and 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.

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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.