General Electric Quality Lead 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). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
He/she ensures each project is developed & released meeting customer expectations and regulatory requirements . The role is a key technical role that works closely with product engineering to ensure Quality System Compliance for
NPI and IB deliverables.
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.
Supports continuous product and process improvement through detailed failure analysis for nonconformances, 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).
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 direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward 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.
This role requires advanced experience in a Quality role in a regulated industry (such as FDA, EUMDD/MDR) with a thorough understanding of the regulations and standards .
Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems.
Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to ISO 13485 and FDA 21 CFR 820.
To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years’ experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.
Relocation Assistance Provided: No