QA Specialist

About the Position

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

This position is to maintain and implement all PMS related activities to fulfill local regulations and global quality requirements, e.g. product complaint handling, adverse event reporting and monitoring, product recall implementation, etc. Key role related to Quality Safety against China GSP requirements. Full-time medical device adverse event monitoring and reporting personnel.

Note: This is a two-year contract position. The selected candidate will be employed by and sign the contract with an external third-party company.

注：此职位为两年期合同岗，录用者将与指定的第三方公司签订合同。

Responsibilities

• Handle the adverse event monitoring, report and evaluation, work with sales and service team for the issue investigation, analysis, and solution. Report the domestic and global adverse event to local authority against local regulation requirements and manufacturing decision. (--30%)
• Responsible for monitoring and follow up of complaint handling by complaint reporter, support the investigation by manufacturing. (--15%)
• Maintain the recall system in China, including but not limited to report liability to local NMPA, follow up of recall/field action status, communication with factories and the closure of recall case (--15%)
• Prepare and submit the product periodic safety evaluation report and/or product risk evaluation report and/or vigilance report against local regulation requirements. (--10%)
• Maintain and update product info in NMPA AE system and monitor customer reported complaint or AE case via NMPA AE system. (--5%)
• Monitor all customer feedback including complaints and make trending analysis report. (--5%)
• Take the responsibilities of PMS related training to all employees. (--5%)
• Establish & maintain PMS/Vigilance related SOP, WI and/or system to be consistent with the latest local regulation and QMS request. (--5%)
• Be coordinator of after-market related quality issue. (--5%)
• Other duties assigned by department head. (--5%)

Requirements

• Bachelor’s degree on subjects of medical device/life science/chemistry or other relevant science
• Minimum 2 years related experience in medical device/pharmacy related quality management, manufacturing, or auditor role
• Previous background and experience in PMS activities
• Strong knowledge and experience in ISO13485, NMPA GxP, AE and recall related regulations

About the Company

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.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.