We, TÜV SÜD AG, use cookies to enhance navigation on our website, analyze website usage, and support our marketing activities. By clicking “Accept all cookies,” you consent to the processing of your personal data for these purposes. Alternatively, you may choose to “Reject all cookies,” which will prevent the use of cookies - except those strictly necessary for the operation of the website. Through the “Cookie settings” button, you may make an individual selection of which cookies you wish to accept. You can withdraw or adjust your consent at any time, with effect for the future, via the Cookie Settings section in the footer. Further information can be found in our Configure CookiesReject All Cookies Accept All CookiesChange the language to explore opportunities in other countriesChange the language to explore opportunities in other countriesChange the language to explore opportunities in other countriesJob DescriptionMedical Device Auditor (Active)We are currently looking for a Medical Device Auditor to join our Medical and Health Service team! You will be performing the audit for active medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices - including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices Regulation (IVDR) and other QMS certification scheme, where applicable.We welcome experts from different medical device industries!For example:
Active devices: active non-implantable surgical devices (Cryoablation, High frequency surgery, High-frequency generator, High-frequency instruments, ablation generators, suction pumps for blood), standalone software, Active Endoscopes, and etc
Ethylene Oxide Sterilisation or other related sterilization
Key Responsibilities:
Perform onsite audits at manufacturer's premises by evaluating their Quality Management Systems in accordance with the requirements of the MDR / IVDR, and other QMS certification schemes such as ISO 13485, ISO 9001 and MDSAP
Maintain customer communication as project leader for the allocated customers regarding auditing and certification, deal with clients' queries relating to certification process including application reviews within acceptable time frames.
Take charge of pre and post audit tasks including preparation of audit documentation and audit package submission
Assist Sales personnel by providing technical advice to existing and prospective clients
Job Requirements:
At least bachelor's degree with diploma in active medical device related major (e.g. Biomedical Engineering, Electronic Engineering, Automatic Control);
Have minimum 4 years of relevant experience in testing of medical device / design and development activities / process validation / application of process technology / service & maintenance in the medical device industry.
Have at least 2 years' experience in Quality Management Systems environment (e.g. manufacturing, quality control, or research)
Qualified auditor for ISO 13485; experience with MDR / IVDR and/or MDSAP is a strong advantage
Clear and articulate presentation ability with excellent communication skills
High level of customer orientation and ability to manage challenging audit situations
Frequent travelling will be required within ASEAN, with occasional travel to other regions
Work Area: Medical Devices & HealthcareCountry/Region: MalaysiaJob Location: Shah AlamWorking Model: HybridEmployment Type: Full time / regularCompany: TUV SUD (Malaysia) Sdn. BOrg Unit Code: MHS-DIVRequisition ID: 3692Duration in months (if limited contract):×Cookie Consent ManagerWhen you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.Required CookiesThese cookies are required to use this website and can't be turned off.Show More DetailsRequired Cookies Provider Description Enabled SAP as service providerWe use the following session cookies, which are all required to enable the website to function:
"route" is used for session stickiness
"careerSiteCompanyId" is used to send the request to the correct data center
"JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor
"Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another
Functional CookiesThese cookies provide a better customer experience on this site, such as by remembering your login details, optimizing video performance, or providing us with information about how our site is used. You may freely choose to accept or decline these cookies at any time. Note that certain functionalities that these third-parties make available may be impacted if you do not accept these cookies.Show More DetailsFunctional Cookies Provider Description Enabled YouTubeYouTube is a video-sharing service where users can create their own profile, upload videos, watch, like, and comment on videos. Opting out of YouTube cookies will disable your ability to watch or interact with YouTube videos.
