Germany Job Openings

Fujifilm Europe

Quality Coordinator

Ratingen

FULL TIME

August 6, 2024

Company Profile:

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.

About the role:

Fujifilm Healthcare Europe is recruiting for a Quality Coordinator to join the QARA team based onsite in Ratingen, Germany.

Responsibilities:

Job responsibilities:

Ensure the quality management system is implemented and maintained in accordance with the requirements of ISO 13485 / ISO 9001 as well as internal requirements
Manage the roll out of standard process and procedures into the local entity & support the quality management system harmonization
Raise & manage nonconformances, CAPAs, Customer complaints, Deviations
Identify potential significant change to the quality management system and support the implementation change
Participate in certification body audits and conduct internal/supplier audits
Be an active member in answering QA related questions
Act as local key person for the companies e-QMS system and ensure Q&A awareness throughout the company
Conduct local quality/regulatory training
Support/assist in day to day regulatory affairs actions

Qualifications:

Ideally 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

Why work with us?:

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!

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