We are looking for a motivated quality manager to join our team in Brazil!
What you will do
- Manage the activities of the quality management system (QMS) department
- Develop and maintain the QMS under regulatory standards and requirements.
- Review quality management, reporting actions to top management
- Participate in internal and external audits (ISO 13485; ANVISA RDC 665/22; customers; EU NB)
- Manage CAPA system
- Be responsible for the go/no go gating of products and processes (working directly with the research & development and process engineering departments)
- Work on developing the product, ensuring that the decision-making is aligned with the requirements of the QMS
- Change the production process as necessary, ensuring that decision-making is aligned with the requirements of the QMS
- Responsible for the Historical Record of the product
- Complaint documentation
- Knowledge of regulatory standards (ISO 13485; ANVISA RDC 665/22) and product development (design and validation checks)
- Fluency in English and Portuguese is required
- Knowledge of the advanced Office package
- Knowledge of and experience with QMS in the medical industry (standard implants, plates, and screws)
- Experience with internal and external audits (ISO 13485; ANVISA RDC 665/22) and CAPA
- Mechanical engineering degree or similar
- Ability to deal with and understand technical difficulties related to the areas of expertise
- Ability to work collaboratively with other technical departments to proactively and pragmatically bring solutions within regulatory standards
- Ability to monitor the QMS through effective reports to senior management
- Ability to represent the company in audits
- Critical and analytical mindset
- Problem-solving ability by identifying the root cause and proposing appropriate actions
Location and type of contract
Working at Materialise
Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.
As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.