Quality Assurance Specialist

Fujifilm Healthcare is focused on becoming a company that can reinforce the advancement of human health through its offering of products and technologies, supporting the transformation taking place in the healthcare sector. Fujifilm Healthcare’s role in Europe involves a commitment to creating new clinical value and improving the medical environment by bringing the latest innovations to healthcare providers, so that they can deliver faster, more accurate diagnosis and treatment to their patients. Fujifilm Healthcare is dedicated to working with healthcare professionals by offering one-stop comprehensive solutions that boost efficiency and automation, leading to a fully patient-oriented approach and a healthier future for people across Europe.

Fujifilm Healthcare Europe is looking for an experienced and motivated Quality Assurance Specialist to join our team based at our European HQ in Ratingen. As a Quality Assurance Specialist you will play a key role ensuring the effectiveness of our Quality Management System & Information Security Management System and support further extensions.

The ideal candidate has experience of working in a quality role for a company manufacturing and/or distributing medical devices.

Approximately 15% travel throughout Europe

Responsibilities:

• Maintain, develop and continuously improve the QMS and ISMS in accordance with the requirements of ISO/IEC 27001 / ISO 13485 / ISO 9001 as well as internal requirements
• Develop, harmonize and implement European procedures in accordance with the company's management systems
• Support future QMS and ISMS extension projects
• Manage Documentation (procedures, records, version control)
• Raise, investigate and & manage Nonconformities, CAPAs, Customer Complaints, Deviations
• Plan, perform and document internal and supplier audits, and support certification body audits.
• Provide QA and ISMS support to cross-functional teams and contribute to the practical implementation of requirements across the organization.

Required Skills and Experiences:

• A degree (Engineering degree, Master, or equivalent) in Quality, Engineering, or a related subject
• Several years of experience working in a quality-based role within a Medical Device company
• In-depth knowledge of ISO13485:2016, ISO/IEC 27001:2022 and ISO9001:2015
• Knowledge of Medical Device Regulation 2017/745 (MDR) is highly appreciated
• Nice to have: ISO 14001:2015(/2026)
• Experience with external audit preparation
• Experience in conducting internal and/or supplier audits and writing clear, actionable audit reports; Lead Auditor qualification is an advantage.
• Ability to turn requirements into workable processes and support stakeholders in their implementation.
• Fluent English; knowledge of other languages is an asset
• Excellent communication skills, personal initiative, ownership.
• 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, colour, religion, sex, sexual orientation, gender identity, national origin, or disability status. At FUJIFILM Healthcare Europe we are proud of our culture which favours diverse thinking, encourages collaboration, and insists on respect and integrity. We aspire to create an energetic, dedicated, and enjoyable work environment for all and hope you will consider joining us!