QA Manager Digital & Software - 5087

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View: 125

Update day: 14-04-2024

Location: Solothurn Solothurn SO

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Full-time

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Job content

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.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.Main Responsibilities
  • 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
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Deadline: 29-05-2024

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