Quality Assurance Specialist

vor 1 Woche


Ratingen, Nordrhein-Westfalen, Deutschland Fujifilm Healthcare Europe Vollzeit

About Fujifilm Healthcare Europe

Fujifilm Healthcare Europe is a leading provider of innovative medical imaging and healthcare solutions. Our company is committed to delivering high-quality products and services that improve patient outcomes and enhance the efficiency of healthcare providers.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team in Ratingen, Germany. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality management system is implemented and maintained in accordance with regulatory requirements.

Key Responsibilities

  • Develop and implement quality management systems to ensure compliance with regulatory requirements
  • Conduct audits and assessments to identify areas for improvement
  • Manage nonconformances, CAPAs, customer complaints, and deviations
  • Participate in certification body audits and conduct internal/supplier audits
  • Provide training and support to ensure quality awareness throughout the organization
  • Collaborate with cross-functional teams to ensure regulatory compliance

Requirements

  • 1+ years of experience working in a quality-based role within a medical device company
  • Good knowledge of ISO 13485:2016 and ISO 9001:2015
  • Knowledge of Medical Device Regulation 2017/745 (MDR) is highly appreciated
  • Experience with audit preparation, lead auditor certificate is an advantage, CAPA management, complaint management
  • Fluent German and English language
  • Excellent communication skills
  • Methodical problem-solving skills and a process-oriented work attitude

What We Offer

Fujifilm Healthcare Europe is an equal opportunity employer and welcomes all applicants for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability status. We offer a dynamic and inclusive work environment that values diverse thinking, encourages collaboration, and insists on respect and integrity.



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