Qa Specialist

CellaVision

Lund, Sweden
On-site with flexibility to work remotely one day per week.
Experience within quality assurance for medical device
Knowledge of iso13485, qmsr (21cfr 820) and ivdr or mdr
Review quality related documentation and procedures
CellaVision is seeking a QA Specialist to ensure compliance with quality management standards in the medical device sector, particularly in digital microscopy. The ideal candidate will possess relevant experience and a positive attitude, while being part of a collaborative work environment focused on innovation and employee initiative

Job Summary

  • CellaVision is a global leader in digital microscopy delivering complete solutions that combine advanced instruments, reagents, and software.
  • The QA specialist ensures the quality management system complies with laws, regulations, and standards such as IVDR, 21 CFR Part 820, and ISO 13485.
  • The role offers a varied, exciting, and occasionally challenging work environment with a lot of responsibility and freedom in a flat organization.

Matching Summary

Match Score: 85

CellaVision is seeking a QA Specialist to ensure compliance with quality management standards in the medical device sector, particularly in digital microscopy. The ideal candidate will possess relevant experience and a positive attitude, while being part of a collaborative work environment focused on innovation and employee initiative.

Skills & Requirements

Must-have

  • Experience within Quality Assurance for Medical Device
  • Knowledge of ISO13485, QMSR (21CFR 820) and IVDR or MDR
  • Review quality related documentation and procedures

Nice-to-have

  • Positive attitude and nothing-is-impossible mentality
  • Ability to communicate and cooperate with internal stakeholders
  • Meticulous person who organizes and prioritizes work efficiently

Key Requirements

  • B.Sc or equivalent in a relevant field
  • Advanced level of English and Swedish written and verbal
  • Experience within Quality Assurance for Medical Device

Work Rights

Not specified

Tailored Resume

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