About Medace
Medace is a unique ISO 13485 certified service provider in the medical industry. We offer a full service work-learning environment. While being taught how to develop their medical product themselves towards clinical implementation and regulatory clearance for market introduction, clients can make use of our R&D and cleanroom facilities and equipment, as well as receive training and obtain advice from our experienced personnel, learning from and building on our QMS template. We offer these in configurable packages allowing our clients to adapt the support they need pending on the product development stage they are in. From access to our state-of-the-art research and cleanroom facilities and equipment, consulting on the smart way to make a compliant development and regulatory roadmap to specific regulated markets, to full collaboration to build the quality management system and technical dossier needed for a clinical grade product.
Our clients range from academic groups in the ideation phase to scale-ups going through the preparations for submissions, with the focus audience consisting of startups active in the field of Medical Devices, Regenerative Medicine and Cell Therapy. This results in a vivid biomedical co-working space where entrepreneurship, science and professionals thrive.
For more information about our company visit www.medacespace.com.
Job Description
As Document Controller, you are a member of Medace’s team reporting to the Head of Quality and will be closely collaborating with the Quality Team. This will mainly involve the set up and administration of the document management system of the QMS.
Initially, the focus will be on implementing the electronic document management system for Medace’s own QMS, after which this will be further rolled out to QMS documentation for the clients.
What are we looking for?
To excel in this role prior experience with document control systems is highly valued. Ideally, you have previous experience with an EN ISO 13485 / GMP certified QMS.
As we migrate towards an electronic document management system, you should be able to handle side-by-side both hardcopy and electronic documents in an organized manner.
In terms of personal character, we are looking for a critical, accurate, and precise person, who is a team player open to broadening their expertise and skill set, including training of personnel.
Responsibilities
· Administrating the document control system;
· Processing documentation and records;
· (Co-)Designing documents, e.g. templates, forms;
· Works with the quality and operations team to develop QMS documentation;
· Support in the development of documentation relevant to client QMS;
· Collaborates in and on quality processes – specifically related to the documents and related records;
· Developing training materials including applicable tests and guidance on document control concepts;
· Reporting on the state of documentation and the document management system.
· Support internal/external audits.
Qualifications
· Preferably (MBO+/HBO) diploma.
· Preferably experience in document control, for instance in the field of Medical Devices or GMP;
· Good command of English, spoken and written; preferably likewise for Dutch;
· Experience with Microsoft office suite, specifically Microsoft Word, Excel, PowerPoint;
· Knowledge of ALCOA++, EN ISO 13485 / GMP.
What we offer
Medace offers a challenging job in an inspiring, fast growing and ambitious organization. Communication lines are short and personal initiative is highly stimulated and appreciated. We offer a market conform full-time position via a one-year contract with a prospect on a permanent employment. We are committed to support your professional and personal development and give you the opportunity to cooperate with talented people in an informal, transparent, and open culture. Working closely with the Quality Team will help develop your skills in advanced QA compliance, document control and training.
Interested?
Please submit your motivation and resume via info@medacespace.com before May 10, to be included in the first round. If you have any questions regarding this vacancy, please contact Jean Blom (QA Manager Medical Devices) via mail: jean.blom@medacespace.com or phone: +31(0)6-2545 7540.
Acquisition as a result of this vacancy is not appreciated!
Due to the characteristics of Medace, we cannot accommodate sponsorships for non-EU citizens.
