Strong quality management experience
Belgium's Siemens Healthineers and Varian entities are Great Place to Work cert
About Our Client
Passion and energy for a great cause are part of our culture and values at Siemens Healthineers.
Our employees are part of our unique position as an employer in the medical technology sector. We empower everyone to grow through a common goal based on continuous innovation in healthcare for the benefit of the patient. Our constant evolution is based on more than 100 years of experience in the healthcare field and more specifically in the world of advanced imaging. Our ambition is to grow and learn, and to enable everyone to grow professionally and personally.
Job Description
1. The Head of Quality and Regulatory is responsible for implementing the requirements of Directive 1_D_79 and the SHS requirements in his/her area of responsibility.
2. Country-wide authority for all applicable SHS QT aspects in coordination with the SHS Country Head and SHS QT.
3. Represents SHS Country Organization in local country QT (QM and RA) community and related activities.
4. Maintains external contacts with legal authorities, trade associations, certification and standardization bodies, and if necessary, with customers and suppliers.
5. Ensures full compliance with local and international regulations and standards affecting SHS products and services.
6. Monitors the regulatory environment to identify potential impacts on the business.
7. Participates in local trade association activities and interacts with health authorities to monitor and influence regulations.
8. Develops and maintains relationships with authorities responsible for medical devices and diagnostic products.
9. Ensures compliance with quality and regulatory requirements related to sales and service activities.
10. Supports the organization in field actions, medical vigilance, and post-market surveillance activities.
11. Maintains necessary licenses for sales and service of products/services.
12. Implements and maintains the organization's Quality Management System, promoting quality consciousness.
13. Implements quality reporting and manages continuous improvement activities.
14. Maintains ISO 9001/13485 certification(s) and acts as Management Representative if applicable.
15. Promotes the SHS Business Principles and QT Vision and Mission.
16. Ensures supplier compliance, manages complaint systems, and has authority to put products on hold.
17. Acts as a role model for HPS implementation, focusing on targeted achievement and process efficiency.
The Successful Applicant
1. Holds a master's degree in biomedical sciences, engineering, or equivalent.
2. Has strong quality management experience and communication with authorities in the medical environment.
3. Ideally, has experience as an auditor.
4. Has solid knowledge of ISO13485 and European regulations.
5. Has strong people management skills and excellent communication skills.
6. Enjoys challenging complex projects, with an analytical, efficient, and solution-oriented mindset.
7. Fluent in Dutch and English, with good knowledge of French.
What's on Offer
1. At least 39 days of leave per year.
2. Competitive salary with fringe benefits including a company car, fuel card (within Europe), vouchers, meal vouchers, and insurance packages.
3. Thorough onboarding and training programs.
4. Pleasant working environment emphasizing work-life balance and activities.
5. A culture of lifelong learning encouraging continuous skill development.
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