
Medical Device Quality Assurance Specialist
3 days ago
Job Overview
We're looking for a Quality Assurance Professional to help us ensure the quality, safety, and regulatory compliance of our products.
- Main Responsibilities:
- Implementing and maintaining a Quality Management System (QMS) in accordance with industry standards.
- Identifying, interpreting, and ensuring adherence to relevant medical device regulations.
- Creating, reviewing, and controlling technical files, regulatory submissions, and internal procedures.
- Providing QA/RA input and support for design and development activities.
- Participating in risk management activities throughout the product life cycle.
- Monitoring device performance, investigating customer complaints, and managing vigilance reporting.
- Supporting the management of supplier quality and compliance.
- Conducting internal audits and leading initiatives to improve processes.
Required Skills and Qualifications:
- Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
- Problem-Solving and Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
- Effective Communication Skills: To coordinate with internal departments and external stakeholders.
- Educational Background: Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
- Previous Experience: Previous experience in QA/RA within the medical device industry is an advantage.
What We Offer:
- A dynamic work environment that supports professional growth and development.
- Competitive salary and benefits package.
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