Fujifilm Healthcare Europe is looking for an experienced Q&R professional to assist with the management of the European Quality Management System. We need someone with a strong background in ISO13485:2016, ISO9001:2015, ISO19011:2018, MDD and MDR who can fulfil a role which sits across both the Quality and Regulatory sides of the department. The ideal candidate has experience of working in a Quality/Regulatory role for a company manufacturing active medical imaging devices.
Fujifilm Healthcare Europe has locations across Europe and is headquartered in Switzerland. The Q&R Specialist role will work closely with all these European teams on anything Q&R related as and when the need arises. This may require travel to the subsidiary to work directly with the team as and when required.
Experience in the building of QMS processes, project management & data analysis are highly desirable.
This position reports to the Head of Services Europe.
Key stakeholders & business partners:
- European Management Team
- Fujifilm Europe
- Fujifilm Healthcare Japan
- Assist in the preparation and hosting of Management Review meetings
- Raise & manage Nonconformances, CAPAs, Customer Complaints, Deviations as needed by the business
- Own and manage Quality System documents and records
- Participate in notified body audits and conduct internal audits
- Be an active member in answering all QA/RA related questions from colleagues/subsidiaries
- Approximately 25% travel throughout Europe
- Assist in day to day Regulatory Affairs actions
- Manage supplier performance via audits & performance reviews to a scheduled timeline
Required Skills and Experiences:
- a degree in Science, Engineering or a related subject
- ideally 5+ years of experience working in a Quality and/or Regulatory based role within a Medical Device company
- in-depth knowledge of ISO13485:2016, ISO9001:2015, 93/42/EEC (MDD), MDR, ISO19011:2018
- experience working with active medical devices is a distinct advantage
- experience with external audit preparedness, Lead Auditor certificate is an advantage
- fluent English; knowledge of other languages is an asset
- excellent communication skills, personal initiative and experience in working as part of a global organization
- 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!
Submit your application consisting of your CV and motivation letter to our HR team at [email protected]
This job is posted in September 2021