Medical Devices QA Manager
il y a 1 jour
**Who are we?**
IBA is a listed company, headquartered in Belgium, and employs 1500 people across the globe mobilizing their skills and passion to Protect, Enhance and Save lives
Innovating for life since more than 30 years, IBA has opened new ways to diagnose and fight cancer and become the worldwide technology leader in the field of Proton Therapy, which is today the most advanced technologies treatment against cancer. Our core particle accelerators knowledge is unparalleled, with 100,000 patients treated on our proton therapy solutions and over 550 accelerators in operation globally.
**One Mission, 4 business lines**
IBA ‘s world class expertise lies in the development of:
next generation Proton Therapy technologies
Radiopharmaceuticals providing oncology care providers with premium quality services and equipment
Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety
particle accelerators for the Industrial and medical world.
Our 4 business lines are employing more than 1,500 passionate professionals worldwide dedicated to our Mission: Protect, Enhance and Save lives.
**Sustainability commitment**
As a company, we are focused on striking the right balance between our stakeholders: increasing our market share and the return for our shareholders, improving the quality of life of our customers, patients and employees, and contributing to the well-being of our society, while also maintaining and restoring our planet’s health.
Check out our webpage sustainability to find out more
**Join us**
At IBA we dare to develop innovative solutions pushing back the limits of technology. We achieved worldwide recognition in our field by supplying the world's top oncologists with the most precise, cancer-defeating, technologies.
If you are passionate, cause-driven, you can make this quest yours by joining our dedicated colleagues and give your career a new meaning.
**Mission**:
The Quality Assurance Manager is responsible for creating and supporting a Quality culture across IBA by driving compliance activities through product life cycle. This includes driving the Quality and Compliance activities for the Quality Management System (QMS) implementation, audits, complaints, CAPA, continuous improvement.
**Challenges we will trust with**
You will:
- Support management and maintenance of the Quality Management System. Ensure it is in place and it is recognized, understood and maintained across the company.
- Communicate internally on the Quality Management System implementation and review progress
- Lead quality to ensure continuous improvement and compliance of the Quality Management System
- Ensure that GMP/Quality Standards/Procedure/Methods/Guidelines are applied
- Lead quality efforts in corporate development of analytical methods.
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implication regarding these changes.
- Provide quality guidance to process improvement projects and programs
- Support efforts to reach GDPR compliance
**What we value**
You have:
- University Degree
- A minimum of 10 years of experience in Quality in ISO 13485 company(ies)
- High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc.
- Excellent level of oral & written communication skills enabling to act as a facilitator and/or educator with strong leadership skills.
- Proficient English
- Qualification as lead auditor ISO 13485 is a plus
You are:
- Adaptable and willing to take on multiple new tasks and responsibilities
- Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time.
- Process orientated, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions.
The identity of IBA is characterized by a group of colleagues driven by motivation, curiosity, creativity, the desire to learn on a daily basis, by technical challenges and above all by a highly developed team and family spirit that makes the daily life smoother and more enjoyable
By joining a team of about 40 nationalities and working on more than 45 different sites on 3 continents, IBA offers you the opportunity of a meaningful career with a direct impact in the fight against cancer.
We are driven by:
- Innovating in a cutting-edge technology environment
- Developing professional and personal skills by learning on the Job; by participating in challenging projects; top class courses
- Evolving in a friendly culture environment based upon solid values (dare - share - care - be fair)
- Acting autonomously and belonging to motivated teams with good work-life balance
- Contributing to a company where sustainability, safety and well-being are key to our success
If you are passionate, cause-driven, you can make this quest yours by joining our dedicated colleagues and give your career a new meaning.
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