Quality Systems Administrator Maastricht • Talentmark

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A dynamic and open work environment with a “get it done” attitude no matter which functional area. You will be part of a dedicated team of professionals all striving for turning our vision & mission into action:
Our vision is to shape Radiology Device business models and support operations in achieving profitable and above market growth – As the Center of Expertise, we deliver best in class performance for key processes, provide governance and manage implementation.

You will work closely together with your manager, the Head of Quality and your colleagues, since it is a small team.

In your job as Quality Systems Administrator, you are in contact with all departments. Apart from that you are also in contact with our legal Manufacturers and our Distribution centers located in Netherlands and Singapore. Also for the Contrast Media Business you will be in close contact with our Responsible Person and the manufacturer.

The great thing about your department is that you will get a lot of freedom in your job and you will work in a fun team. Additionally, you have a lot of contact with your colleagues in different departments, while you are coordinating our efforts to provide great service.

You will love working in our open office space because it makes the collaboration with your colleagues even better. If you feel like having a chat, simply step into one of the coffee corners. If you need to focus, there are one-person offices to do so. In our meeting rooms, you even get to write on the walls. We also have the option of somedays to work from home.

Job Description

• Manage and controls Document Control and collaborates with the QMS Training Systems to ensure and promote that process outputs and QMS requirements have been met according to local procedures and in alignment with Global SOP’s & International standards.
• System owner of systems used in Quality team..
• Monitor, analyse and control QMS KPI’s related to Document Control and Material hold to support continuous improvements initiatives at BMC BV
• Accountable and responsible to manage and maintain the Contrast Media Quality Management Systems supporting the Responsible Person(s) and Quality Head to maintain supplier qualifications, CAPAs, training, SOP updates, internal audits, Quality Management Review, QAA management for Contrast Media business between BMC BV and other legal entities, among others.
• Support new business models and changes in the Medical Device and Contrast media business (e.g. Go Direct projects).
• Acts as a point of contact and expert on deviations for commercial operation and CAPAs. Perform root cause analysis for the deviations associated towards quality management system topics.
• Support improvements or business needs towards product or system, per request.
• Management of Material Holds for BMC BV and collaborates with the Global Team of Issue and Complaint Management. Coordinates with affiliates material holds returns to BMC BV/Legal Manufacturer when needed.
• Maintain close communication with Legal Manufacturer, Repair Shop, Warehouse & Transportation team and Radiology Distribution Centers (RDCs) to support product related activities (e.g. rework activities, scrap, among others).
• This position could execute multiple reports to provide inputs for the Site Quality Management Review (SQMR) and monthly KPI reporting.
• Handling and archiving of quality records for data accuracy and integrity to support product quality related activities.
• Support training activities when needed regarding quality related topics such as: GxP, Data Integrity, ISO 13485, EU MDR, FDA.
• Acts as a backup as needed for other activities per management discretion.

Job Requirements

• Bachelor’s degree required.
• Minimum of 2 years of experience in Quality, Projects Administration or equivalent.
• Experience with Document Control and GxP related activities.
• Experience handling non-conforming product.
• Proficiency in Microsoft Office programs including Word, Outlook, Excel, PowerPoint required.
• Proficiency in documentation management required.
• Ability to handle multiple concurrent projects and prioritize accordingly.
• Enjoys working in a multicultural environment.
• Demonstrated ability to multi-task and meet tight deadlines.
• Ability to work effectively with cross-functional teams.
• Effective written, listening, and verbal communication skills (English required).
• Strong organizational skills.
• Strong competency in Customer Focus, Driving for Results, Flexibility.
• Achiever, Adaptability, Communication, Accurate, Learner.

Remote work: possible, max. 1-2 days work from home.
Interview: online, 1 or 2 interviews in total.