Medical Device Specialist
il y a 2 semaines
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- Clinical, Qualification & Validation, Quality management, Regulatory affairs, Software validation
Are you an expert within medical devices and passionate about helping companies in this area in their growth or to achieve their ISO13485 certificate? Apply now for the job of Medical Devices Specialist at QbD
Table of Contents
As a QbD Medical Devices Engineer, you will be working on several projects within ISO13485 environments or you will help companies achieve their ISO13485 certificate. You are a communicative versatile person, capable of solving problems, investigating root causes, and implementing changes.
What do we expect from you as a Medical Device Specialist?- You are capable of conducting internal audits regarding ISO13485, Quality management systems, Quality Assurance, etc.
- You will be responsible for the implementation/maintenance of Quality Management Systems according to ISO13485.
- You have an eagle eye for optimizations within quality and quality systems and are able to implement them.
- In this role, you work in close collaboration with production, QA, engineering, QC, process/validation engineers, supply chain, etc.
- We count on you for the development of Standard Operating Procedures (SOP), related Work Instructions (WI), forms, checklists, protocols, and reports.
- As a project consultant, you are responsible for the tracking and reporting on project deliverables.
- You are able to coach a small team but also to work independently.
- You are responsible for preparing all documentation for filing to authorities.
- We expect you to follow regulations on medical devices and share your insights/knowledge within the QbD team and at our customers.
- You support in setting up the timelines for the go-to-market strategy in light of the applicable regulations and the customer’s business plan.
- Scientific master’s degree: engineer (bio, industrial, civil), industrial pharmacist, etc.
- Experience in the life science industry and in GMP, preferably in medical device projects.
- Knowledge of quality system standards (ISO 13485), regulatory standards for Medical Devices (21CFR820 & EU MDD/MDR) or software used for Medical Devices (IEC 62304) is a big plus.
- First experience with audits is an advantage.
- Good project management skills.
- A true QbD’er can be recognized by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challenge; Hungry for knowledge: You are always open to learning; No BS mentality: you can be straightforward in a respectful way; Innovative: You are constantly looking for new and better solutions; (Not too) serious: your job is serious, but you don’t take yourself too seriously.
An attractive and complete salary package:
- A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.
But most of all…
- We offer sustainable careers and meaningful connections.
- We are a knowledge-based company.
- You’ll work for an award-winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, etc.
- As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
- Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
- In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done
Send us your CV and motivation letter and who knows, maybe you’ll find your #QbDream job.
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