Created in 2013, Wishbone is an innovative start-up located in Flemalle (Liege). Wishbone is engaged in the development of intraoral bone regeneration biomaterials. The company is launching its industrialization and production activities in a brand new production unit.
The goal of Wishbone is to develop superior bone graft substitute products with breakthrough technologies and innovative procedures, and thus improve patient well-being and contribute to a better environment. For more information please visit: www.wishbone-biotech.com
To support this challenging development, we are looking for a (m/f):
Quality Assurance Manager
As a Quality Assurance Manager, you are responsible for managing the Quality and Regulatory functions. You ensure the company and the products are compliant with the appropriate standards and regulations. You provide support in the Quality Management System implementation and maintenance. This includes the development of systems, policies/procedures and programs to ensure compliance with the FDA regulations, ISO standards, and other international requirements.
Your main responsibilities are:
- Manage the Quality Management System according to the EU ISO 13485, the US FDA 21 CFR Part 820 and any other relevant regulatory requirement in accordance with the Quality Policy.
- Ensure that required processes of the Quality Management System (QMS) are documented, established, implemented and maintained.
- Assure that products have been supplied, manufactured, analyzed and released according to specifications and approved SOP’s and to appropriate standards and regulations.
- Organize and document the Management Review according to the company QMS. Recommend and drive improvements.
- Perform supplier audits, internal and external audits and interact with suppliers and customers to deal with non-conformities and drive continuous improvement.
- Support activities for CE marking and FDA approval certification of products as well as maintaining the documentation up to date when changes to the product occur, dealing with notifications and amendments when required.
- Manage materiovigilance activities including incident and post-market surveillance reporting.
- Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Report to the top management on the effectiveness of the Quality Management System and any need for improvement of the company organization.
- Scientific Master’s degree, or equivalent through experience.
- At least 5 years of experience in QA management positions in the medical devices industry.
- Strong understanding of regulations and guidelines governing medical devices (e.g. CFRs, ISO 13485, MDD, MDR).
- Strong leadership, project management and communication skills together with hands-on and pragmatic mind-set.
- Ability to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essential.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in English. Any other language is a plus.
- The opportunity to join an innovative medical device company, a fast-growing start-up environment where teamwork, results and patient care are very important.
- A challenging and diversified position in a dynamic, young and professional
- To work in a human size, dynamic, respectful and professional environment.
- An attractive compensation package in line with the position responsibilities and your experience.