Quality Assurance Engineer Jobs in GE Health Care - Bangalore

Bangalore, Karnataka

5 - 6 yrs Exp.

Not Disclosed

15 Mar 2023
5 Applicants
987 views

Job Description

Responsibilities:

GE Healthcare Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics.
Ensures quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Supports continuous product and process improvement through detailed failure analysis for nonconformance and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills.
Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.
Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters.
A job at this level requires good interpersonal skills for cross function collaboration .

Qualifications/ Skills:

Required Qualifications

This role requires domain knowledge and work experience in ISO 13485 and IEC 62304(Software Development Life Cycle - SDLC) standards
Education qualification level is comparable to a Bachelor's degree from an accredited university or college .
5 plus years of experience in healthcare/medical device industry

Desired Characteristics

Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs.
Demonstrated understanding of Medical Device QMS(Quality management System) requirements and regulatory requirements including but not limited to FDA ( US Food and Drug Administration ) 21 CFR (Code of Federal Regulations) 820, IEC 62304-2006 (Medical Device Software Standard), and ISO 13485.

Key Skills

ISO 13485 IEC 62304 SDLC Medical Device QMS FDA 21CFR IEC 62304-2006

Other Details

Education

Any Graduation/Diploma

Employment Type

Full Time, Permanent

Industry

Medical / Healthcare / Hospitals

Funtional Area

Healthcare

About Company

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE HealthCare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform

Job Source : https://jobs.gecareers.com/healthcare/global/en/job/GE11GLOBALR3698361EXTERNALENGLOBAL/Quality-Assurance-Engineer

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