Medical Device Compliance Specialist
2 weeks ago
Tata Consultancy Services is seeking a skilled Quality Engineer to join our team in aMedical Device Industry.
Key Responsibilities:
1. Provide technical support on organization's quality processes within QMS.
2. Work with cross functional teams and internal teams to create deliverables.
3. Interpret new/ upcoming quality/ regulatory requirements and provide guidance.
4. Meet delivery promise in terms of budget and timescales.
5. Track Project progress and make necessary changes to project execution as needed to ensure achievement of project goals.
Requirements:
1. 6-8 years of experience in Medical Device Industry.
2. Understanding on Medical Device Quality and Compliance.
3. Knowledge on ISO 13485: 2016 and 21 CFR 820.
4. Experience Complaints Handling, Post Market Surveillance.
5. Knowledge on Medical Device Regulatory Standards, MDD and MDR.
6. Medical Devices Risk Management.
7. Able to adapt to changing/emerging data requests from a variety of different system applications.
8. Experience in Medical Device Industry Quality and Compliance.
9. Experience in interpretation of regulations, standards and performing impact assessment on Quality system documents.
10. Ownership to close CAPA, driving risk management activities.
11. Experience in Post-Market-Surveillance, Complaint Management of Medical Device.
About Us:
TCS is a global leader in IT services, consulting and business solutions. We are a part of the Tata Group, one of India's largest and most respected business houses. We are a leader in the industry, with a strong presence in over 50 countries.
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