Senior Associate Specialist - Quality

I00M05 Wipro GE Healthcare Private Limited; Karnataka; On-site; INR 1,200,000 - 1,400,000; Full time

Job summary

GE HealthCare in India (Karnataka) seeks a seasoned Quality professional to drive regulatory compliance and quality culture across products and processes. The role collaborates with product engineering to ensure QMS compliance for medical device deliverables and NPI programs.

The ideal candidate has extensive experience in regulated industries, strong communication skills, and a track record of CAPA-driven improvements. This is a senior individual contributor role with cross-functional exposure.

Qualifications

• Advanced experience in a Quality role in regulated industry (FDA/EUMDD-MDR) with thorough understanding of regulations.

Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region.
• 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 including metrics, reporting and CAPA.
• Supports continuous product and process improvement through detailed failure analysis for nonconformances and implements corrective/preventive actions (CAPA).
• Developing in-depth knowledge of a discipline and applying it to policy/strategy.
• A job at this level is likely an individual contributor with interpersonal skills.
• Communicates with colleagues and business about design and coordination services.
• Provides guidance to new team members and explains complex information clearly.
• Impacts projects, processes and procedures in own field and works with autonomy within standard practices.
• Uses professional judgement and may require senior guidance.
• Utilizes technical expertise to solve problems and leverage internal sources.

Skills

Quality management

Regulatory compliance

Analytical thinking

Education

Bachelor's degree or equivalent

Job description

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.

Job Description Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region.
• 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.

Required Qualifications

• 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).
• Experience of plus 8 years in the relevant industry .

Desired Characteristics

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.

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.

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.

Additional Information

• Relocation Assistance Provided: No

At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.