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Biocon Biologics Limited
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Design Quality Engineer (Contract To Hire)

Design Quality Engineer (Contract To Hire)

Biocon Biologics Limited

4 - 6 years

5 - 10 Lacs

Bengaluru

Posted:1 month ago| Platform:

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Skills Required

Design Verification Medical Device Design Medical Devices Design Review Medical Equipment Medical Device Product Development DFMEA Mdr Design Validation

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Work from Office

Job Type

Full Time

Job Description

DESIGNATION: ANALYST DESIGN QUALITY ENGINEER Contract Duration: 12 - 24 Months PRIMARY RESPONSIBILITIES: Ensures that designs meet regulatory requirements, quality standards, and company policies throughout the product lifecycle (FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, ISO 14971) Review design documentation, specifications, and data to identify potential compliance gaps and quality issues. Responsible for developing and implementing compliance programs, identifying potential issues, and recommending corrective actions to ensure product safety, reliability, and efficacy. Maintain accurate and up-to-date documentation related to compliance activities, including test results, reports, and procedures. Hands-on experience in Design History File compilation / Technical file documentation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance. Possess a strong understanding of design principles, quality control standards, regulatory requirements, and problem-solving methodologies. QUALIFICATION: A graduate in Mechanical or related engineering and with 4-6 years related medical device /combination product design & development experience and product lifecycle management.

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Biocon Biologics Limited

www.biocon.com

Biopharmaceuticals

Bengaluru

7000+ Employees

41 Jobs

Key People

Kiran Mazumdar-Shaw

Executive Chairperson
Christophe Huber

Chief Executive Officer
Ranjit Shahani

Deputy Managing Director

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