Quality Systems Specialist
6 days ago
About the Job:
This role involves maintaining our Quality Management System in compliance with MDSAP (ISO13485: 2016) and FDA 21CFR Part 820 regulations. As part of the team, you will also contribute to the development of our products through assembly, testing, installation, and servicing activities.
Main Tasks:
- Develop and implement strategies for ensuring compliance with regulatory requirements
- Collaborate with cross-functional teams to design and manufacture high-quality medical devices
- Stay up-to-date with industry developments and emerging trends in RA/QA and medical devices
Essential Qualifications:
- At least 5 years of experience in RA/QA roles within a medical device company
- Bachelor's degree in a relevant field; postgraduate studies or certifications are considered advantageous
- Proven expertise in creating, managing, and auditing quality documents and records according to FDA guidelines
Workplace Conditions:
This role involves spending significant time working at a computer, participating in meetings, and communicating with colleagues and stakeholders. The individual selected for this position must demonstrate adaptability and flexibility to meet the demands of the role.
Travel Policy:
Occasional business travel is required for training, meetings, and other official purposes.
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