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Quality Assurance
7 days ago
Position - Quality Assurance Engineer (Medical Devices)
Industry Preferences - Medical Devices
Location - Delhi NCR
**Job Description -**
Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.
- Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
- Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
- Participate in design reviews during various phases of NPD.
- Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
- Expert-level knowledge of current industry standards for New Product Development and risk management practices.
- Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
- Exposure to any Programming language & on Software Testing concepts.
- Design And User Validation exposure.
- Good interpersonal and communication skills.
**Required Skills -**
Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
- AQE should drive coordination with different departments (such a R&D, Test, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective.
- Experience on NPD process and various phases of new product development.
- Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
- Design and User Validation.
- Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
- Knowledge of IEC 62304 standard for Medical device software.
- Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
- Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.
**Job Types**: Full-time, Permanent
**Salary**: ₹1,300,000.00 - ₹1,800,000.00 per year
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Fixed shift
- Monday to Friday
Supplemental pay types:
- Yearly bonus
Work Location: In person
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