We're looking for Medical Device Quality Management System Engineer /Manager
Overview: We are looking for a detail-oriented Medical Device Quality Management System (QMS) Manager/Engineer to join our team. This role involves ensuring the effective implementation and maintenance of quality management systems in compliance with industry regulations and standards.
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) for medical devices.
- Conduct internal audits and facilitate external audits to ensure compliance with CE, FDA regulations, ISO standards, and other applicable requirements.
- Collaborate with cross-functional teams to address quality issues and drive continuous improvement initiatives.
- Create and update quality documentation, including procedures, work instructions, and forms.
- Support risk management activities, including hazard analysis and failure mode effects analysis (FMEA).
- Provide training and support to employees on quality processes and best practices.
- Analyze quality data and metrics to identify trends and areas for improvement.
Qualifications:
- Bachelor's degree in Biomedical Engineering, Quality Assurance, or a related field.
- 3+ years of experience in quality management within the medical device industry.
- Strong knowledge of CE, FDA regulations, ISO 13485, and other relevant standards.
- Excellent analytical and problem-solving skills.
- Strong communication and teamwork abilities.
