Associate Specialist Quality

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Develop and maintain systems rules and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.

Job Description

Roles and Responsibilities

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 while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives metrics reporting and operating mechanisms.
Applies general knowledge of business developed through education or past experience. Understands how work of own team contributes to the area.
Resolves issues using established procedures. Consults People Leader or more senior team members for issues outside of defined parameters.
Collaborates with others to solve issues. For customer facing roles develops strong customer relationships and serves as the interface between customer and GE. Exchanges technical information asks questions and checks for understanding.
Handles simple data entry work requiring face value check and correction.

Required Qualifications

Bachelor degree in Engineering
5 years of relevant experience in Quality Assurance preferably in Medical Devices Pharma or Life Sciences industry.
Strong understanding of ISO 13485 FDA 21 CFR Part 820 & risk management ( ISO 14971).
Hands on experience in Supplier qualification Audits Change control Document control and validation.
Proficient in CAPA process and use of Problem solving tools.
Quality Engineer in medical device manufacturing Repair and Refurb ensures compliant reliable and efficient production processes by providing daily quality oversight leading investigations for nonconformances and CAPA driving process validations (IQ/OQ/PQ) and applying risk management tools such as FMEA and control plans.
The role focuses on improving yield reducing defects and supporting audits while ensuring adherence to ISO 13485 FDA QSR and MDSAP requirements.
This engineer collaborates closely with crossfunctional teams mentors junior staff and uses datadriven methods like SPC capability studies and Lean/Six Sigma practices to strengthen product and process quality across the manufacturing lifecycle.

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

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Additional Information

Relocation Assistance Provided: No

Required Experience:

Job Description SummaryDevelop and maintain systems rules and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Developing conceptual knowledge of professional discipline. May include ...