QRC Specialist

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

To support the business in SEA region, including Vietnam, in all aspects of quality and regulatory compliance.

Duties & Responsibilities

• Familiar with ISO 13485, ISO 9001.
• Implement and maintain QMS in SEA region, predominantly Vietnam, including coordinating annual inspection audit, and management review activities.
• Support in QMS related activities, e.g., monthly review, audits, process reviews, and improvements, CAPA, complaints, etc.
• Manage Adverse Event reporting according to local regulation and Global SOP.
• Coordinate and execute Field Safety Coorective Action (FSCA) per local regulation and Global SOP.
• Compile and prepare product registration packages and other relevant licenses applications, change notifications, renewals.
• Ensure timely update of product registration details in databases in a compliant and timely manner.
• Source documents and guidelines, consolidate file and maintain product technical Information.
• Keep close track of changes in country regulatory requirements and provide regulatory intelligence on the current and upcoming new regulations/ guidelines.
• Perform all other duties assigned by the Company and/or Manager.

Requirements

• Proficiency in both English and Vietnamese (spoken and written) is mandatory.
• Willingness to relocate permanently to Vietnam after an initial period based in Singapore.
• Diploma/ Degree in Biomedical/ Science/ Engineering or other relevant fields.
• 1-2 years of relevant experience in QA/ RA, preferably in medical device industry.
• Familiar with ISO 13485/ ISO 9001 and possess knowledge in Medical Device regulations.
• Responsible, work independently, detail oriented.
• Able to manage and prioritize multiple projects and tasks to meet deadlines.

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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.