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You control your data Ambu uses cookies on Ambu websites but will not collect any of your personal data (such as your IP address or other identification factors) as it is anonymized. Accordingly, Ambu will not be able to see where you come from or where you are going on the internet after you leave our websites site. We do not sell or otherwise disclose information about how our users navigate and use our website. We do not sell or disclose information about your purchase history to third parties. You can read more about Ambu’s use of cookies in our cookie policy on Ambu websites. By clicking 'Accept all' you consent to all these purposes. You can also choose to indicate what purposes you will consent to using the check boxes below, then press 'Save Settings'. You can always withdraw your consent by pressing the small icon in the lower left corner of the page. Read more about cookies Google privacy policy Select all Strictly necessary Strictly necessary cookies help make a website navigable by activating basic functions such as page navigation and access to secure website areas. Without these cookies, the website would not be able to work properly. Functional Functional cookies make it possible to save information that changes the way the website appears or acts. For instance your preferred language or region. Statistical Statistical cookies help the website owner understand how visitors interact with the website by collecting and reporting information. Marketing Marketing cookies are used to track visitors across websites. The intention is to display ads that are relevant and interesting to the individual user and thus more valuable for publishers and third-party advertisers. Unclassified We are in the process of classifying unclassified cookies together with the providers of the individual cookies. DECLINE ALL SAVE SETTINGS ACCEPT ALL powered by: Cookie Information Senior QM R&D Engineer I , as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies About us Jobs Our People Hiring process Values Language View profile Job Description Job Alerts Link Apply now open/close Print local Share on Twitter Share on LinkedIn Send as email Senior QM R&D Engineer I City: Penang Country/Region: Malaysia State: Business Area: Quality Assurance Department: Global Quality Management R&D Employment Type: Full-time Req ID: 9735 Responsibilities: Participate in new product development and project design change for global products. Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality. Handle change control, especially be the expert in process validation for global products. Participate in the critical quality issue which required QAE attention in the project as required. Involve in NCR/ CAPA activities as required. Maintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change. Other QM R&D function, as identified. Requirements: Degree in science or equivalent. Min 2 years in Quality Assurance or Quality Engineering. Knowledge in ISO13485. Experience in product development, project management and/or design control. Innovative, committed with good accountability. About Ambu Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific. For more information, please visit ambu.com or follow us on LinkedIn. Apply now SHORTCUTS See all products See all clinical evidence Find distributors Ambu addresses Contact us Research Support SHORTCUTS Financial News Job openings SOCIAL MEDIA Opens In A New Tab. Opens In A New Tab. Opens In A New Tab.