Quality and Regulatory Affairs Manager
We are looking for a passionate professional to be part of our team as a Quality Manager.
This job position represents a good opportunity for Quality Assurance Experts who have the desire to develop their career in the quality field in the biomedical industry. The candidate will report directly to the company CEO and manage all aspects of quality including obtaining and maintaining the Quality Management System, defining the critical processes required for IVD product development, including risk management and design control, conducting continuous improvements and developing quality plans for continued success.
The work will require strong interdisciplinary relationships, both with R&D team within the company and with various stakeholders in the healthcare sector.
- Obtain and maintain the ISO-13485 quality management system
- Develop and manage design and development processes for IVD products
- Manage product verification and validation
- Develop risk assessment and risk management procedures
- Supplier management and auditing
- Coordinate internal and external audits
- Master’s degree or higher education in Engineering/Life Science discipline
- Team leader with strong analytical skills
- ISO 13485 knowledge
- Experience on risk management procedures (e.g. ISO 14971)
- Expertise with risk assessment tools (e.g. FMEA)
- Min 3 years’ experience in Quality Assurance area
- Biomedical industry experience
- Proficient in English
- ISO 13485 experience
- Knowledge of FDA Quality System Regulations
- IVD regulation knowledge
- Software programming knowledge