Quality Manager, Innovation Translation Center

vor 3 Wochen

Zizers, Schweiz AO Foundation Vollzeit

The AO is a medically-guided, not-for-profit organization, a global network of surgeons, and the world's leading education, innovation, and research organization specializing in the surgical treatment of trauma and musculoskeletal disorders. We are home to people from all over the world, from different backgrounds, with diverse talents and specialist areas. What binds us together is our passion for excellence, our dedication to our mission of improving patient care, and our understanding that we are stronger together: we are one AO.

In close collaboration with trusted industrial partner, universities and in-house institutes, the AO Foundation constantly develops new operation techniques, implant, instruments and clinical solutions under the medical guidance of independent surgeons. The AO is the leading innovator in the surgical treatment of bone fractures and disorders. Innovation at the AO goes from bench to bedside, including basic research and innovation, product development, and clinical validation. The AO Innovation Translation Center (AO ITC) streamlines and drives innovation projects. As part of the AO ITC, together with Clinical Science, Clinical Operations is the AO's clinical research provider. With about 30 clinical research specialists (project managers, clinical research associates, study assistances, image research associates, medical advisers, medical statisticians, data mangers, medical writers and quality and vendor managers) we produce clinical evidence by the planning and execution of international clinical studies that is highly relevant to current trauma and orthopedics practices for better patient care.
- Employment Type: Permanent- Part-time percentage: 80-100%- This position is located in: Zizers, CH- Experience level: Experienced professional-
**Job Facts**:

- Work location: Zizers /Landquart (1h commute with train from Zürich HB)
- Hybrid work model: 2-3 days/week in the office required

**Main Requirements**:
Education
- BSc preferably in natural science or similar
- Education as "Qualitätsmanagement Beauftragter TüV" or similar

Job specification
- Ability to develop and manage a quality management system in compliance with regulatory requirements
- Knowledgeable about ICH E6 and ISO 14155 and regulatory requirements (Swiss, and basic knowledge about EU, USA)
- Ability to scout for regulatory updates and updates of ICH guidelines and ISO standards
- Ability to work both, independently and in a team and to communicate effectively
- Proficiency using MS Office including Word, Excel, PowerPoint
- Ability to work in a document management system and/or to use other QMS IT systems
- Strong written and oral communication skills in German and English
- Ability to perform internal Quality Control of projects
- Preferably ability to perform Audits internal and external (if trained to do so)
- Teaching skills to train employees and vendors on QMS and regulatory updates

**Main Responsibilities**:
In general (QMS)
- Maintenance, implementation, inspection, and continuous improvement of AO ITC Clinical Evidence quality management system
- Ensure alignment of the top management with the QMS (business requirements in accordance with relevant regulations)
- Review, revise and maintain quality documents vs. ISO 9001 standards (ie ISO 14155), ICH guidelines and applicable regulations
- Develop new processes in collaboration with process owner and provide expertise for process development and documentation

In general (regulatory compliance)
- Scout for new and/or revised regulations (Switzerland, EU, USA, any other country as required based on operational activities)
- Scout for new and/or revised standards and norms (ISO, ICH)

Education of employees
- Ensure compliant introduction of new employees in collaboration with the AO HR and the assigned line manager
- Ensure (and perform) adequate training (introduction and continuous) in the QMS, regulations and guidelines
- Ensure the Function and Competency profiles are in line with the QMS and organizational chart(s) of the organization
- Ensure documentation of external and internal continuous education of the employees in accordance with the QMS
- Ensure the CVs of the employees are available in accordance with the QMS
- Ensure the specific needs as defined in the AO ITC Clinical Evidence QMS are aligned with the AO Foundation HR
- Ensure correct hand-over and documentation for leaving employees (in alignment with the AO Foundation HR)

External collaborators (vendors)
- Support Manager Clinical Services in ensuring adequate training of contracted staff (vendors)
- Support Manager Clinical Services in quality control and quality assurance activities of contracted staff (vendors)

Quality control and quality assurance
- Plan, execute and follow-up internal quality control activities (internal project audits) according to the QMS
- Plan, execute (if competent) and follow-up audits of investigation sites and vendors (in collaboration with the M

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