Quality Inspector Job Description:

We are currently searching for an experienced and highly-analytical Quality Inspector to join our Quality Assurance department. As the Quality Inspector, you will uphold the safety regulations of our company and supervise the product flow process to guarantee that all our products meet quality and Regulatory guidelines expectations.
To excel in this role, applicants should demonstrate great attention to details with excellent technical and interpersonal abilities.

Duties:

Manufacturing Quality Monitoring

  • Act as a Quality advisor for manufacturing process & layout changes
  • Monitor all process to meet Regulatory guidelines (FDA, EU and other applicable regulations)
  • Monitoring online production quality results, allocate risks and implement solutions
  • MRB Management
  • Assists & Support internal and external quality system audits
  • Inspect and monitor US site Quality process.
  • Supplier Quality monitoring including Suppliers audits, survey and ongoing quality aspects
  • Monitor Calibration of test equipment
  • Support special activities and projects of the Senior QA&RA Manager.

Design Quality Support:

  • Ensure FDA, EU and other regulatory requirements are meet in Design Control process.
  • Participates in the Design Reviews, design transfers and in all other aspects of the Design Control process.
  • Monitoring product development activities and documentation, especially Design Review meetings, Risk Analysis meetings.

Required Qualification:

  • 3+ Years of relevant experience in Medical Device industries
  • Previous experience of Global regulatory requirements such as: FDA (QSR) and EU MDD/MDR, ISO requirements
  • CQE (Certified Quality Engineer) qualification
  • Strong written/verbal communication skills
  • English: fluent
  • Well organized, Highly motivated and independent
  • Team player