Description
We are looking for a
E-Health Quality Consultant (m/f)
Reference: -en
Start: ASAP
Duration: 6 MM
Place: near Geneva
Branch: Wettbewerber
Your tasks:
- Act as quality management representative in selected development projects, in the field of e-health software, including web-based and mobile applications
- Ensure design control compliance in accordance with ISO 13845 and 21 CFR 820
- Identify the applicable quality and regulatory standards
- Review and approve all project deliverables (internal and from suppliers), including software requirements, specifications, verification and validation documents
- Participate in risk management and software development activities in accordance with ISO 14971 and IEC 62304
- Participate in design reviews, approve/disapprove move to next phase
- Compile the regulatory submission file for US, in accordance with the applicable FDA guidance documents
- Compile the technical file and ensure CE mark approval
- Support regulatory submissions worldwide
- Ensure alignment with drug development and regulatory teams Quality Assurance
- Participate in supplier qualification and audits
- Review and approve change control, deviations and CAPAs
- Assess new or revised regulations and standards
Your qualifications
- Master or PhD
- Training in IT systems compliance (data privacy, security, regulatory)
- Training in software development life cycle, preferably in the medical device domain (ISO 13485, 21 CFR 820, IEC 62304, ISO 14971 and FDA software guidelines)
- Global and international orientation
- Confident personality able to make independent decisions
- Supportive, keen to promote quality through example and continuous support
- Profound experience in quality systems for medical devices
- In-depth experience in web-based or mobile applications software development or software project management activities
- Experience with design control process for medical devices
- Experience with current medical device regulations for the EU and US
- Fluent in English (excellent writing skills)
Skills:
- Quality manager
Keywords: Qualitätsmanager