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QLTY & RELIABILITY ENGINEER II


At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

The Quality Engineer - NPD will provide Quality support to our New Product Development team in ensuring prototyping/manufacturing processes are developed to meet customer requirements, and the regulatory requirements of medical devices manufacturing. The quality engineer will form part of a cross-functional team and including process development engineers with varying expertise in areas relating to medical devices processing

What your background should look like:

Responsibilities
•    Participate in the New Product Development business as the quality voice in the development team - ensuring that quality is built into all component products through all stages of the product life cycle 
•    Ensure product development process and project team achieve and maintain compliance to the Quality Management system in all aspects of the New Product Development process.
•    Ensure that process development projects are delivered to comply with required industry process validation principles.
•    Experience in Risk Management especially Risk Analysis according to ISO 14971
•    Familiar with procedure and documentation generation and applying Lean principles to establishing process instructions.
•    Establishing inspection standards, plans, sampling frequencies and test methods, and familiar with practical application of quality engineering tools.
•    Performing reviews of established production and system procedures to identify efficiency enhancements and prevention of errors. 
•    Identifying and implementing effective production and process controls to maintain product quality.
•    Work with suppliers and customers on the resolution of product quality issues and identify quality improvement programs to sustain supplied material quality.
•    Proficient in the use of quality engineering tools and ideally applying statistical software to support process investigations and identifying improvements.

Qualifications
•    Experience of 5 to 8 years in Medical Device Quality Assurance
•    Prior experience in the Medical Device industry in design and development of Medical Devices
•    Experience with implementing product changes through a structured, phase-gated, product development process is desired. Good understanding of medical device product development risk management methodologies (FMEA, etc.)
•    Ability to apply a structured problem-solving approach and Six Sigma tools and methodology familiar is an advantage.
•    A strong knowledge of ISO 13485 and 14971 in both domestic and international regulatory environments related to medical device quality assurance
•    Good knowledge of standards and regulations (ISO 13485, 21 CFR 820, ISO 14971, EU MDR, etc.) affecting medical devices marketed in all regions throughout the world would be plus
•    Ability to work in a cross-functional team; Good written, speaking and listening skills in English
•    Certified Internal Auditor for ISO 13495:2016 would be a plus
•    Strong organizational, interpersonal and communication skills
•    Ability to communicate effectively with all levels of organization and the ability to work effectively in an international multicultural organization
•    Act for Change: embrace change and innovation and initiate new and improved ways of working

Competencies

Values: Integrity, Accountability,Teamwork, Innovation
Location: 

Bangalore, KA, IN, 560066

City:  Bangalore
State:  KA
Country/Region:  IN
Travel:  None
Requisition ID:  76067
Alternative Locations: 
Function:  Quality


Job Segment: Manufacturing Engineer, Engineer, Quality Manager, Risk Management, Lean Six Sigma, Engineering, Quality, Finance, Management

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