Quality Assurance Engineer

  • Randstad
  • Lausanne, VD, Switzerland
  • 03/11/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics

Job Description

Our client, an innovative company within medical devices industry in Lausanne is looking for a

Quality Assurance Engineer

Start: Asap
Permanent employment

Your mission:

  • Continuously improve the company quality system by analyzing KPIs and data such as complaints, non-conformances, CAPAs etc., reporting trends and providing solutions to any quality and technical issues affecting compliance
  • Proactively investigates, identifies, and implements best-in-class Quality Assurance practices in regulated industries
  • Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with ISO13485 standard and FDA / EU Regulations
  • Interface directly with IT, Engineering and Vendors to develop CSV strategy
  • Provide support for quality system processes and best practices
  • Provide Quality compliance expertise and support as required by the organization
  • Create or review documents prepared by stakeholder (e.g. plan, protocols, reports, change controls)
  • Assist in resolution of deviations/ exceptions during qualification activities
  • Oversee and administer document lifecycle management as well as the Document Change Request process
  • Perform final approval of documents submitted through the change control process for format, completeness and review
  • Handle company Quality Audit process
  • Conduct QA-RA intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards
  • Conduct training on quality assurance concepts and tools to the organization
  • Managing the site calibration program, the coordination of calibration activities and associated documentation.

Education & Skills:

  • Bachelor of Science in an engineering or applied science discipline
  • 2-5 years' experience in the healthcare industry
  • Detailed knowledge of FDA Quality Systems Regulations, ISO 13485, 21 CFR part-11 and other global regulations and standards
  • Experience with statistical analysis concepts and techniques
  • Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly

Language skills:

  • Fluent in English (level C1) with minimum B2 level in French