Job Information
GE Healthcare Sr Lead Specialist Quality - Healthcare Quality in Bengaluru, India
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 purpose is to create a world where healthcare has no limits. 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
GEHC ONLY 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.
Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with peers direct colleagues and the business teams about manufacturing quality management requirements and compliance design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in simple terms, collaborates with cross functional teams, effectively utilizes influencing skills to handle straightforward complex situations.
Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
Required Qualifications
Engineering Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 10+ years of experience in Job Family Group(s)/Function(s)).
This role requires advanced experience in the Quality & Healthcare Quality preferred in Medical Device manufacturing quality.
Medical devices/ Pharma background will be plus.
Desired Characteristics
Qualified internal auditor (ISO 9001, ISO 13485)
Exposure to various country regulations in medical devices
Understanding on Risk Management, CAPA Process
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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support
Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud
Additional Information
Relocation Assistance Provided: No