Auditor IVD Medical Devices Stellenangebote


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2 Jobs für Auditor IVD Medical Devices


Stellenangebote Auditor Ivd Medical Devices Jobs


Job am 02.12.2025 bei Jobleads gefunden

Quality Assurance Manager

• Köln, Nordrhein- Westfalen Bio Talent Cologne, North Rhine-Westphalia, Germany Quality Assurance Manager Bio Talent, a transformative Device company focused on developing new class 1 + 2 devices for a range of products, is [...]
MEHR INFOS ZUM STELLENANGEBOT[...] hiring a QA Manager to set up and lead our Quality Assurance and Regulatory Affairs operations. What this role will offer you Work in a fastpaced environment and make a significant impact. Be one of the first team members within the quality team. Exposure [. .. ] Support internal and external auditing in a frontoffice facing role. Lead QMS updates and maintain documentation, including risk management and design history files. Requirements Handson quality experience within device or IVD products in ISO13485. Lead internal and supplier audits; ideally a certified lead auditor. Track record of updating QMS. Experience with CAPA, postmarketing, NCR, complaints management. BSc or MSc in a relevant Life Sciences subject. If you want to be part of an innovative, growing company where you can expand your knowledge, get in touch by emailing or calling +41 460 85 32. Seniority level Mid Senior level Employment type Fulltime Job function Quality Assurance and Production Industries Medical Equipment Manufacturing and Manufacturing Referrals increase your chances of interviewing at Bio Talent by 2x. #J-18808-Ljbffr 71169119 [. .. ]

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Job am 01.10.2025 bei Jobleads gefunden

Regulatory Technical Reviewer (m/f/d) - Healthcare

• Plattling, Bayern [. .. ] for the clinical assessments of product on an as needed basis. Delivers assigned projects within agreed timescales. Reviews test data and reports. Participates in assessments. Qualifications Bachelors [...]
MEHR INFOS ZUM STELLENANGEBOT[...] degree in technical, medical or scientific university or polytechnic studies or comparable professional knowledge. 5+ years of relevant experience in management system certification in the field of medical devices. Profound knowledge of the relevant regulations, directives and guidelines for certification of Md/IVD devices (Regulations (EU) 2017/ 745 and 2017/ 746) , relevant MDCGs as well as the role of the Notified Body. Profound knowledge of global medical device conformity assessment programs (e. g. , MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA) . Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under regulatory conformity assessment procedures. Qualification as management system auditor in the healthcare sector. Strong interpersonal skills; self-starter; good decision-making skills and organizational skills. Technically competent to evaluate all products, including new and unique products, with assistance of other technical staff as necessary. Ability to manage multiple assessments and changing schedules and deadlines with supervision. Demonstrates technical competence [. .. ]

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Die meisten Stellenanzeigen für Auditor IVD Medical Devices Jobs werden derzeit in Nordrhein-Westfalen (1 Jobs), Bayern (1 Jobs) und Niedersachsen (0 Jobs) angeboten.


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