Responsibilities:
- Develop and execute validation and verification protocols (IQ, OQ, PQ) to ensure processes and products meet specified requirements.
- Prepare and maintain documentation required for regulatory submissions and audits, such as Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).
Experience:
- Medical device industry experience
- Minimum 2 years of experience in Project management
- Strong communication skills
- Strong problem-solving skills
- Familiarity with software tools like Microsoft Office Suite
Qualification:
• BE/BS - Mechanical Engineering
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