Quality Assurance Specialist

Vor 7 Tagen

Ratingen, Nordrhein-Westfalen, Deutschland Fujifilm Healthcare Europe Vollzeit
Fujifilm Healthcare Europe: A Leader in Medical Device Quality

We are seeking a highly skilled Quality Assurance Specialist to join our QARA team based in Ratingen, Germany. As a key member of our team, you will play a crucial role in ensuring the quality management system is implemented and maintained in accordance with ISO 13485 / ISO 9001 requirements.

Key Responsibilities:
  • Implement and maintain the quality management system, ensuring compliance with regulatory requirements.
  • Manage the roll-out of standard processes and procedures, harmonizing the quality management system across the organization.
  • Raise and manage nonconformances, CAPAs, customer complaints, and deviations.
  • Identify potential significant changes to the quality management system and support implementation.
  • Participate in certification body audits and conduct internal/supplier audits.
  • Act as a local key person for the company's e-QMS system, ensuring Q&A awareness throughout the organization.
  • Conduct local quality/regulatory training and support day-to-day regulatory affairs actions.
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.

We are an equal opportunity employer and welcome all applicants for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability status. At FUJIFILM Healthcare Europe, we are proud of our culture, which favors diverse thinking, encourages collaboration, and insists on respect and integrity. We aspire to create an energetic, dedicated, and enjoyable work environment for all.

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