At TÜV SÜD Group we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group.
Your Tasks:
-Perform onsite audits at manufacturer’s premises by evaluating their Quality Management Systems in accordance with the requirements of ISO/EN ISO 13485, ISO 9001, EU MDR/IVDR, MDSAP and other schemes.
-Ensure, that audit is compliant to relevant internal procedures, standards and regulations.Draw up records and report on the corresponding audits.
-Keep up to date for relevant regulation and procedures.
-Collaboration with audit teams and stakeholders.
-Gather relevant objective evidence during audits by reviewing documentation, interviewing personnel and observing processes.
-Evaluate audit results to identify non-conformities, deviations, and areas for improvement, Compile comprehensive report, follow-up on corrective actions.
-Drawing clear conclusions from the audit and provide additional information as requested to support final review and certification decision-making.
-On-time completion of trainings and authorizations.
-Handle a group of clients and respective projects upto date and follow-up for audit planning.
-Handle client data confidentially and timely.
Your qualifications:
Gradulation in biology or microbiology, chemistry or biochemistry, mechanical engineering or bioengineering, human physiology, medicine, pharmacy.
Minimum of four years of full-time work experience in the field of medical devices or related sectors (e.g., medical device industry, healthcare, medical device audit or research in medical devices)
Knowledge in Medical Device Quality Mangement System,
Knowledge in EU and International Regulations on Medical Devices,
Certification or Training (If any required),
Not Mandatory but prefered QMS LA on ISO 13485 or ISO 9001
Awareness program on EU / International Regulatory frame works on Medical Devices
Other trainings on risk management, including risk analysis, process validation, sterilization and related processes.
Four years work expereince in Design, Manufacturing, Application of the medical devices/Two years audit experience with medical device- ISO 13485:2016/MDR/MDSAP.
At TÜV SÜD Group, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives.
We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Group Code of Ethics and Company values.
We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD Group. Click here to find out more about Diversity at TÜV SÜD Group.