Director of Quality Assurance
vor 3 Monaten
**Deine Verantwortung**:
- Sie leiten und führen personell den Bereich QM / RA mit drei Mitarbeitenden.
- Sie sind verantwortlich für die Leitung des Qualitätsmanagementsystems nach EN ISO 13485, MDR, FDA 820 und GMP.
- Im Rahmen der PRRC sind Sie zuständig für die Prüfung der Konformität der Medizinprodukte, die technische Dokumentation (auch deren Aktualität), Marktüberwachung und das Meldewesen.
- Sie stellen sicher, dass das Qualitätsmanagementsystem gemäß EN ISO 13485, MDR, FDA 820 und GMP, alle Medtech Prozesse gemäß den geltenden Anforderungen, die Wirksamkeit und Aufrechterhaltung des QMS sowie die Durchführung von Behörden
- und Zertifizierungsaudits gewährleistet sind.
- Sie setzen die operativen Ziele um unter Berücksichtigung der Termin-, Qualitäts
- und Kostenziele.
**Deine Skills**:
- Mindestens 5 Jahre Berufs
- und Führungserfahrung im Bereich Qualitätsmanagement der Medizintechnikbranche oder in einer ähnlichen Funktion
- Mehrere Jahre Berufserfahrung im Bereich Regulatory Affairs in der Medizintechnik branche von Vorteil
- Gute Kenntnisse der ISO 13485:2016 und der EU MDR 2017 / 745
- Erfahrungen im Projekt
- und Prozessmanagement und Auditieren
- Analytische und konzeptionelle Denkweise, selbständige und proaktive Arbeitsweise
- Sie kommunizieren fliessend in Deutsch und Englisch (schriftlich/mündlich)
**Benefits**:
- ** Gute Verkehrsanbindung und Erreichbarkeit**:
- ** Komfortables Büro mit moderner Infrastruktur**:
- ** Interessante und abwechslungsreiche Tätigkeiten/Projekte**:
- ** Eingespieltes und dynamisches Team**:
- **Flache Hierarchien**:
- ** Internationales Umfeld**:
- ** 13. Monatsgehalt**
**ROCKEN Jobs**:
**Profil erstellen**:
2 - 5 years
-
Director of Quality Management
vor 7 Monaten
Bern, Schweiz Panda International Vollzeit**Director of Quality Management (QMS)**: **Location** - Bern, Switzerland **Business Sector** - Biotechnology **Job ref** - 22245 **Published** - 3 days ago Our client, a biotech company at the forefront of innovation, is seeking a Director of Quality Management to continue their growth trajectory in Switzerland. **Key Responsibilities**: - Develop...
-
Quality Assurance Manager
vor 7 Monaten
Bern, Schweiz Panda International Vollzeit**Quality Assurance Manager**: **Location** - Bern, Switzerland **Business Sector** - Pharmaceutical **Job ref** - 22249 **Published** - about 7 hours ago Our client, a renowned pharmaceutical company based in Switzerland, is seeking a highly skilled and experienced Quality Assurance Manager to lead and oversee the quality management functions within the...
-
Quality Assurance Manager
vor 7 Monaten
Bern, Schweiz BMK Recruitment VollzeitWe are currently looking on behalf of one of our clients based near Bern for a Quality Assurance Manager. This is a permanent role. Aufgaben - manage tests on products at different stages of production to ensure the quality level - define the measurement procedures - be the central point of contact for product test-related matters - be the central point of...
-
Sr. Director, Site Quality Head, Bern
vor 7 Monaten
Bern, Schweiz Johnson & Johnson VollzeitFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the...
-
Aseptic Process Quality Assurance Expert
Vor 5 Tagen
Bern, Bern, Schweiz Consultys VollzeitAt Consultys, we are expanding our team with a highly skilled Aseptic Process Quality Assurance Expert. This critical role will play a vital part in ensuring the highest standards of quality and compliance in our aseptic cleanroom facilities.About the RoleWe are seeking an experienced professional with a strong technical background in sterility assurance,...
-
Quality Assurance Architect Consultant
vor 3 Monaten
Bern, Schweiz Consultys VollzeitDue to the substantial increase in our business, we are currently looking for a Quality Assurance Specialist, to join our team of consultants.Supports creation and implementation of the aseptic operator training program for the siteCreation and update of procedures and risk assessmentsEnsures adherence to global procedures and standardsCreation of SOPs in...
-
Quality Assurance Tester
vor 7 Monaten
Bern, Schweiz Oliver James Associates VollzeitQuality Assurance Tester Bern Hybrid We've partnered with one of the leading health techs whose mission is to shape the future of healthcare technology. They are seeking individuals who are passionate about innovation and eager to contribute to the ongoing development of the hospital information system. They are dedicated to revolutionizing healthcare...
-
Quality Excellence Director QA/qs At
vor 8 Monaten
Bern, Schweiz Johnson & Johnson VollzeitThe Quality Excellence Director QA/QS, Advanced Therapies Platform, is responsible for delivering the Quality Assurance (QA) and Quality Systems (QS) platform strategy. This role will develop, execute, and monitor Advanced Therapies Quality (ATQ) projects, budget and strategies, and establish robust business and quality processes and systems to monitor...
-
Medical Director Pathology Switzerland
Vor 6 Tagen
Bern, Schweiz Unilabs VollzeitIntroduction Unilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people. Your Tasks To work in line with the company's goals, strategy and management system for quality, environment, information security and work environment and participate in operations and business...
-
Bern, Bern, Schweiz CSL Behring VollzeitWe are seeking a highly skilled Global Quality Assurance Manager to join our team at CSL Behring. This role will be responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and providing quality oversight for outsourced operational activities.The successful candidate will have a thorough understanding of...
-
Sterility Assurance Expert
Vor 4 Tagen
Bern, Schweiz Hobson Prior VollzeitHobson Prior are currently looking for a Sterility Assurance Expert to join a fantastic biotech establishment on a permanent basis located in Bern. Our client is focused on improving and saving as many lives as possible. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this...
-
Software Quality Assurance Specialist
vor 2 Monaten
Bern, Bern, Schweiz ONE Agency | IT Recruitment Experts VollzeitWe are looking for a Software Quality Assurance Specialist to join our team at ONE Agency | IT Recruitment Experts. This role involves creating and implementing comprehensive test plans and executing various types of tests in collaboration with the project leader and development team.Ihr AufgabenbereichErstellen Sie Testkonzepte und -spezifikationen auf der...
-
Global Lead, Sterility Assurance
vor 24 Stunden
Bern, Schweiz CSL Behring Vollzeitas a Global Lead Sterility Assurance - Validation Controls, you will be responsible for establishing the CSL standards and for global Quality oversight related to validation aspects of the company’s sterility assurance and contamination control concepts. You will report into the Global Head of Sterility Assurance and will be a part of a global team of...
-
Quality Assurance Architect
vor 7 Monaten
Bern, Schweiz SettleMint Vollzeit**Accelerating the Web3 transformation journey**: We are a venture-funded global scale-up, and we recently closed our series-A funding of €16 million, co-led by Molten Ventures and OTB Ventures. We reached a new phase of growth, and we are now going to expand our operations and teams really fast, with clients in financial services, retail, manufacturing,...
-
Director, Head of Bioinformatics
vor 2 Wochen
Bern, Schweiz CSL Behring VollzeitYour Role In the role of Director, Bioinformatics & AI you will lead a team focused on the method development and application of computational approaches for addressing scientific questions in pre-clinical research and translational medicine; focusing on genetics, omics, imaging, biomedical literature, and RWD data modalities. As a member of the biomedical...
-
Director, Head of Bioinformatics
vor 4 Wochen
Bern, Schweiz CSL Behring Vollzeit**Your Role** **Your Responsibilities** Reporting to the Senior Director, Global Head of Data Science you will: - Support and implement a robust and inclusive recruitment and talent development strategy to attract talent, and provide scientific and career development mentorship - Work across Global Research organisation with therapeutic area leads,...
-
Head of Lab Execution Systems, Senior Director
vor 2 Monaten
Bern, Schweiz CSL Plasma VollzeitThe OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...
-
Associate Director/director Business Operations
vor 7 Monaten
Bern, Schweiz Johnson & Johnson Vollzeit**Associate Director/Director Business Operations** Leading and developing the Business Operations department which provides: E2E material mgmt. incl material planning based on production schedule as well as logistics & warehousing; direct and indirect procurement for the site; Business services resource supply/demand planning and the local Reliability Room...
-
Quality Assurance and Regulatory Affairs Manager in
vor 2 Monaten
Bern, Schweiz Unilabs VollzeitIntroduction Unilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people. Your Tasks - Promote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in...
-
Scientist Quality Assurance Clinical Research
Vor 4 Tagen
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...