Medical Device RA/QA Consultants and Trainers - Europe
ONLY CANDIATES WITHIN THE US, WITH 10 PLUS YEARS PROFESSIONAL EXP WILL BE CONSIDERED
Oriel STAT A MATRIX provides consulting and training support to medical device manufacturers around the world. Our team of consultants/trainers is comprised of both full-time employees and independent consultants (the latter of whom we call affiliate consultants). By using a combination of employees and affiliate consultants, we maintain a robust consulting team. This allows us to provide a wide breadth of experience and expertise for our clients’ projects.
At the present time, we are looking to expand our team by adding more affiliate consultants who have had their own consulting firm for at least 2 years. Applicants should also have a minimum of 15 years of medical device industry experience, particularly in the following disciplines:
- Quality Assurance
- Regulatory Affairs/Compliance
- Compliance and Auditing
- Performance Improvement Methodologies in a Regulated Environment
- Quality System Improvement
- Development of Global Harmonized Quality Management System
- Enhancement of Corporate Processes, optimized for performance
- Selection and implementation of document management systems
- Product Portfolio Prioritization
- Identification of products and product families
- Assessment of product performance
- Technical File gap analysis and closure
- Compliance to new European Medical Device Regulations (MDR)
- Immediate response to TUV findings including one Class IIa and one IIb tech file reviews
- Master Data and IT Infrastructure Development
- UDI implementation
We work closely with our affiliate consultants to understand their needs and wants, so we can ensure that the relationship provides mutual benefits for both them and our company – this ultimately leads to highly satisfied customers.
All of our affiliate consultants have their own businesses and clients; many take assignments from other organizations as well. We work with our affiliate consultants to understand how much of their time they would like us to fill, and we do our best to meet these requests. We also seek to learn what types of projects each affiliate prefers to work on (e.g., long-term consulting, training, international projects, etc.). By understanding how we can best complement and supplement each affiliate consultant’s business, we can maintain long-term relationships for our mutual success.Company DescriptionOriel STAT A MATRIX has been a leading consulting and training provider specializing in performance improvement for close to 50 years. Our global client base consists of corporations, public and private institutions, and government agencies. With trainers and consultants in 33 states and 18 countries, and a comprehensive expertise in a wide range of performance process methodologies. We help customers successfully compete in the global marketplace. To learn more about us, please visit www.orielstat.com.