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Senior Quality Assurance Engineer
2 weeks ago
We are seeking a Senior Quality Assurance Engineer to join our team at g2 Recruitment. As a Quality Engineer, you will be responsible for ensuring compliance with international quality standards in the development of medical devices for drug delivery systems.
Key Responsibilities:- Ensure compliance with FDA and ISO 13485 standards.
- Conduct risk assessments and support design control activities.
- Maintain and review documentation for regulatory compliance.
- Collaborate on process improvements and manage supplier quality.
- Support audits and change management processes.
You will work closely with R&D, manufacturing, and regulatory teams to uphold quality and drive continuous improvement throughout the product development lifecycle.
Qualifications:- Bachelor's degree in Engineering or a related field.
- 3+ years of experience in quality engineering (medical device or pharma).
- Knowledge of ISO 13485, FDA regulations, and risk management.
- Strong communication and problem-solving skills.
- Experience with drug/device combination products is a plus.
