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QA Manager – Digital & Software – 5087 (ADA)
Our client is a leading Medical Technology company in Switzerland. It is headquartered in Central Switzerland and has a global network of production sites, subsidiaries and sales partners. For our client’s Quality and Assurance department, we are looking for a Quality Assurance Manager – Digital & Software for a permanent role to be based in Central Switzerland area.
- Ensure a common standard within the company with regard to quality and regulatory requirements.
- Provides full product lifecycle quality oversight including all pre-production (i.e. Plan, Design, Validation and Release) and post-production (i.e. availability management, problem management, change control, etc.) for commercial and digital health assets, mobile applications including health software and SaMD applications
- Reviews/approves technical documentation constituents
- Provides necessary guidance and support to meet design control requirements
- Ensures outstanding inspection readiness for systems in the portfolio
Qualifications and Experience:
· Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field is preferred
- ITIL, Agile, and/or Scrum Master certifications are a plus
- At least 4 years of dynamic experience in the pharmaceutical/medical device/biotech or other regulated industry is required
- Knowledge of Software as Medical Device (SaMD) is desired, including ISO 13485, IEC 62304, IEC 82304, ISO 14971
- Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is mandatory