(Senior) QMS Engineer - Medical Devices

Mô tả công việc
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About the Role:
In this role, you will assists QA manager for medical device quality system and regulatory management in manufacture process, you will play a critical part in driving innovation, solving complex challenges, and delivering meaningful impact. This is an opportunity for someone who is curious, action-oriented, and motivated to push boundaries in a fast-paced environment.
This is where your SharkNinja journey begins. You're an explorer-not a tour guide-driven by curiosity, fueled by taking chances, and unwilling to fly under the radar. Here, bold moves turn into real impact, growth comes from challenge, and your work helps shape what's next.
LOCATION: Vietnam.
Here are some of the EXCITING things you'll get to do:
Responsible for implementing and improving the medical device MFG quality system, ensuring its continued compliance with relevant requirements.
Attend design transfer meetings and be responsible for implementing and improving the medical device production quality system, ensuring its compliance with relevant requirements.
Manage and review batch records and related documents in the medical device production process.
Report on the operation of the medical device MFG quality system and drive the resolution of MFG NCs.
Evaluate the compliance and effectiveness of the quality system during the medical device MFG process, participate in internal audits and management reviews, promptly provide feedback and quality improvement suggestions.
Assist in the promotion and training of medical device manufacture related regulations and product standards.